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Senior Compliance Specialist-logo
PfizerSanford, North Carolina
Use Your Power for Purpose Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients. What You Will Achieve This position reports to the Manger of Operations Compliance at the Sanford site. The position is responsible for maintaining compliance, inspection readiness, cGMP auditing, manufacturing CAPAs, manufacturing change controls, commitments (PQS, audit response, and CAS reports), manufacturing risk assessment facilitation, and interactions with internal and external Regulatory agencies (FDA, EMEA, etc.) Key focus is the oversight quality related requirements for operations areas and executing tasks to ensure full cGMP compliance. The Senior Compliance Specialist is accountable for supporting manufacturing functions to optimize compliance and productivity across Sanford Operations. Working in strong partnership with Engineering, Maintenance & Utilities (EMU), Technical Services, Quality, EHS, and Operational Excellence. This SME will provide core support to the overall compliance and success of the 24/7 operations team. Will accompany internal and external Regulatory auditors and interact with agencies during cGMP inspections. Will provide and assist in audit responses. It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It Change control ownership for operations Manufacturing ownership for CAPAs Manufacturing risk assessment facilitation System administrator for data integrity reviews and account recertifications Audit readiness and responses Manufacturing point of contact for commitments Ensuring compliance with Standard Operating Procedures (SOPs), current Good Manufacturing Practice regulations (cGMP), and corporate policies and safety practices Focus on Safety and GMP Compliance as operational priorities and as performance measures that should be included in metrics. Self-motivated and able to adapt to rapidly changing priorities. Strong oral and written communication skills. Participate in and may take a lead in decision making process. Engage and inspire their team members on performance expectations and coach the team to meet those expectations using Coaching Skill principles. Lead and support continuous improvement efforts, where applicable. Be a role model to support a positive compliance culture. Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data Integrity principles. Here Is What You Need (Minimum Requirements) Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience. Demonstrate experience in compliance, project management, and system administration in a multi-layered organization Experience in two of the following areas is desired: Manufacturing, Materials Management/Planning, QA, QC, Technical Services, and Engineering. Bonus Points If You Have (Preferred Requirements) Formal experience in the Manufacturing, Technical, or Quality organizations is highly desired. PHYSICAL/MENTAL REQUIREMENTS Job will require regular walks and observations within the manufacturing facilities. Non-Standard Work Schedule, Travel or Environment Requirements Nonstandard work schedule may be required to support site regulatory inspections. OTHER JOB DETAILS Last Date to Apply for Job: August 27, 2025. Referral Bonus Eligibility: YES Eligible for Relocation Package: NO The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Quality Assurance and Control

Posted 6 days ago

4
4MATIV TechnologiesMinneapolis, Minnesota
Description ABOUT 4MATIV TECHNOLOGIES, INC. 4MATIV Technologies manages multi-modal mobility for school systems nationwide with technology to expand options and enhance service. We envision a future where all children have access to the learning opportunities that maximize their potential, and we are reimagining transportation to accelerate student outcomes. We partner with schools to improve service, safety, and holistic sustainability, ensuring all students have access to the right ride. Currently, we manage transportation for over 50 school districts across cities including Houston, Indianapolis, Minneapolis-St. Paul, and Phoenix, simplifying operations and expanding services for families. Every school day, 4MATIV manages outsourced vendors and operates a contact center supporting more than 22,000 student trips across over 1,000 routes for schools across the country. Our team is committed to: Working shoulder-to-shoulder with our clients as a mission-aligned and trusted partner Building user-centered products to create lasting impact for districts and students Valuing diversity of perspectives and experiences Care for every detail and outcome Highest standards of service and safety Constant learning and improvement POSITION OVERVIEW The Operator & Compliance Manager is a key member of our team that provides key oversight over the vehicle operators we subcontract on behalf of our customers. The Operator & Compliance Manager supports the VP of Routing and Operator Services in monitoring operator performance and regulatory compliance within their assigned market, and leads field oversight and on-the-ground support and interventions with operators . This role requires a proactive, field-based approach, ensuring transportation services operate efficiently, safely, and in compliance with contractual and regulatory standards. A flexible schedule is required to meet operational demands, particularly during peak periods such as school launch planning, start-of-year transitions, and high-volume service adjustments. This role requires extensive on-the-ground presence with our operators in Minneapolis/St.Paul, conducting site visits, trailing buses with reported behavior concerns, and investigating service disruptions in real time. LOCATION Minneapolis/St. Paul, MN Hybrid schedule: remote work with frequent in-person responsibilities RESPONSIBILITIES Operator Performance Management Oversee operator service reliability and adherence to performance standards, focusing on high-priority issues. Conduct targeted site visits, ride-along, and other field deployments as directed or as necessary to assess service quality and investigate observed recurring concerns or those raised by schools or account managers. Provide coaching to underperforming operators based on data-driven insights, while standard training is managed by support teams. Partner with internal teams to optimize problematic routes and reduce major service disruptions. Regulatory Compliance & Safety Oversight Assess operator compliance with local, state, and federal safety regulations, collaborating with the Compliance Team for reporting and audits. Act as a liaison between operators, schools, and regulatory agencies for major compliance concerns. Address high-risk safety incidents and coordinate corrective action plans Support risk mitigation strategies in partnership with Safety & Compliance Coordinator handling documentation and compliance tracking. Field Oversight & Incident Response Investigate chronic service failures (e.g., repeated missed stops, recurring safety concerns) instead of all daily incidents. Conduct on-site ride-alongs and stop reviews for high-priority escalations. Report field findings to internal teams for data-driven improvements, while routine adjustments are managed by Routing & Dispatch. Relationship Management Serve as the primary point of contact between operators, schools, and internal teams, fostering strong communication and accountability. Work collaboratively with school administrators and stakeholders to resolve service-related concerns. Build trust and engagement with operators to ensure alignment with 4MATIV’s service expectations. Technology & Compliance Monitoring Oversee the use of safety technologies, including video monitoring systems and compliance tracking tools. Track and analyze operator performance data, flagging trends for continuous improvement. Ensure proper documentation and reporting of compliance records for internal and external audits. Requirements Education & Experience Bachelor's degree in business administration, transportation management, logistics, or a related field preferred. 5+ years of experience in transportation operations, vendor management, or a similar role. Experience working with school transportation or contracted fleet operations is a plus. Knowledge of DOT, FMCSA, and other regulatory safety standards preferred. Core Competencies Leadership & Accountability – Ability to take ownership of operator performance and drive improvements. Problem-Solving – Strong analytical skills with the ability to assess challenges and implement solutions. Field Presence – Willingness to be actively engaged in the field, conducting site visits and monitoring service delivery. Communication & Relationship Building – Strong ability to build rapport and foster productive working relationships. Adaptability & Initiative – A proactive approach to managing service disruptions and operational challenges. Schedule Flexibility – Availability to adjust work hours based on operational needs, with heightened focus during peak times such as launch planning and school start periods. Benefits Salary Range: $75,000 – $90,000, per year Benefits: 401(k) Dental insurance Flexible schedule Health insurance Paid time off Parental leave Vision insurance

Posted 30+ days ago

Assistant Environmental Compliance Specialist 1-logo
GAI ConsultantsCanton, Ohio
GAI Consultants is seeking an Environmental Specialist with experience in Field Compliance Monitoring to be based out of our Canton, OH /Columbus, OH office, within our Power & Energy Business Unit. This position is mostly remote and will require travel to various project sites regional to the Upper Midwestern and Mid-Atlantic Regions. Applicants should enjoy working in a challenging, fast-paced, and team-oriented environment. This position will afford an excellent opportunity for the individual to expand their experience and knowledge base in federal and state environmental regulations and methodologies in primarily in Ohio, but also with opportunities in Michigan, Indiana, Pennsylvania, West Virginia, and Maryland). The successful candidate will serve as a field lead to perform, with minimal supervision, various assignments including, but not limited to those listed below. Essential Duties and Responsibilities: Performing field monitoring of erosion and sediment (E&S) controls on various types of construction Projects (linear and site-based) while working independently. Review and understand specifications, permits, and permit conditions as well as E&S control and stormwater plans associated with both site and linear construction Projects. Prepare and review periodic monitoring reports based upon field observations. Reports may be submitted via paper report or electronically as required. Assist with the preparation of environmental reports, permit applications, and closeout requests such as wetland and stream delineation reports, erosion and sediment control plans, and sound studies. Agree and adhere to the Health and Safety requirements of GAI Consultants and GAI’s clients. Maintain QA/QC standards and adhere to the Quality Management System procedures of GAI Consultants and the quality procedures of GAI’s clients. Qualifications Required: Excellent written and verbal communication skills and technical writing ability. Ability to utilize electronic location devices such as a GPS or a GPS enabled device to collect data tied to a Project location. Candidate must be proficient in using Microsoft (MS) Word, Excel, and MS Office applications and be familiar with report, database, and form completion through both MS Word applications (e.g., Access, SQL) and online programs. A valid driver’s license along with ability pass required screening to drive a GAI vehicle. Must be flexible. Travel will be expected as part of this position. Regional travel for various construction projects (2-5 hours round trip). 3-5 days/week, year-round. Some office time will be available. Preferred: ( Not required, but candidates that demonstrate these qualifications will be given preference) Minimum of an Associates (A.S.) degree from an accredited college with an engineering/environmental/science focus. Two to four years of demonstrated experience in field monitoring. Consideration will be given to candidates that can specifically show E&S control monitoring or similar experience. Experience performing Environmental Due Diligence (i.e., Phase I/II Environmental Site Assessments). Knowledge of National Pollutant Discharge Elimination System (NPDES) regulations and permitting and familiarity with environmental agency E&S control guidelines and best management practice (BMP) designs, construction, and maintenance. Consideration will be given to candidates that can demonstrate experience and Comprehension of E&S control BMP concepts, designs, and maintenance requirements. Past experience working with an environmental review agency (e.g. state or local conservation district) either for the agency or with the agency as a consultant or owner. Experience in SWPPP, NPDES Permit Application and/or Erosion and Sediment Pollution Control Plan Development. Proficiency with AutoCAD and/or GIS (ArcGIS). Experience in environmental compliance such as air compliance and/or spill response planning a plus. Knowledge of Section 401/404 permitting, stream and wetland surveys, delineation techniques, and permitting. Certifications: Qualified Environmental Inspector (PA), Responsible Person for Erosion and Sediment Control (MD), Certified Erosion, Sediment, and Stormwater Inspector (CESSWI) 90% for regional travel. 3-5 days/ week, year round. (2-5 Hour Round Trip) Physical Demands and/or Other Job Information: Ability to walk moderate distances through unimproved terrain, utility rights-of-way, in remote areas, etc. Ability to lift up to 50 pounds. Ability to hear and visualize potential hazards during fieldwork or site visit situations. GAI Consultants prides itself on the quality of its employees and as such, candidates who receive a job offer will be required to successfully pass a drug screening. General Characteristics Shows progress in acquiring basic skills; follows procedures; learns record keeping protocols general topographic and arial photograph reading experience, learns technical literature basics, available for frequent travel and field work. Minimum Years of Experience 1 to 2 Years of Experience Education Bachelor's Degree in Environmental Sciences or similar field of study Technical Responsibilities Introduction to ecological field data collection, wetland delineations, basic regulatory agency applications, gains knowledge of regulatory requirements, and other duties as required; receives technical training for career enhancement Project and Task Management Responsible for personal task management and adherence to deadlines and scope. Management Responsibility Close supervision on all work assignments. No managerial responsibilities at this level. Communication Skills Why GAI? Possesses basic oral and written communication skills. Identifies and acknowledges principles of teamwork and leadership. Interacts primarily with internal project team members At GAI, exceptional people have an exceptional place to work, grow, lead, and achieve. Explore an array of opportunities in locations across the U.S. and join accomplished colleagues in tackling challenging projects for a range of markets. Enjoy comprehensive benefits and feel good about being part of a collaborative team that’s committed to supporting the communities we serve. Join GAI and distinguish yourself in a company poised for unlimited growth. Benefits To Working at GAI Include: Competitive salary - GAI is committed to paying market-based salaries Comprehensive benefits package including medical, vision, dental, company paid Long Term Disability, and Short-Term Disability (benefits start within 30 days of hire) New paid Maternity/Paternity/Adoption program Generous Paid Time Off and 7 paid holidays  401k company match Tuition Reimbursement

Posted 1 week ago

Quality Technician, UL Compliance & Final Inspection-logo
CrusoeTulsa, Oklahoma
Crusoe is building the World’s Favorite AI-first Cloud infrastructure company. We’re pioneering vertically integrated, purpose-built AI infrastructure solutions trusted by Fortune 500 companies to power their most advanced AI applications. Crusoe is redefining AI cloud infrastructure, with a mission to align the future of computing with the future of the climate. Our AI platform is recognized as the "gold standard" for reliability and performance. Our data centers are optimized for AI workloads and are powered by clean, renewable energy. Be part of the AI revolution with sustainable technology at Crusoe. Here, you'll drive meaningful innovation, make a tangible impact, and join a team that’s setting the pace for responsible, transformative cloud infrastructure. About This Role: As our Quality Technician specializing in UL compliance and final inspection, you will be a key contributor in ensuring that our manufactured products meet stringent Underwriters Laboratories (UL891) requirements and our internal quality benchmarks before shipment. You will be responsible for interpreting UL standards, implementing inspection protocols to verify compliance, and executing the final inspection stage to guarantee product functionality, safety, and adherence to specifications. Your comprehensive understanding of UL regulations, meticulous attention to detail, and strong expertise will be critical in upholding our commitment to quality and safety. You will collaborate closely with engineering, manufacturing, and quality assurance teams to ensure seamless integration of UL requirements throughout the production process. This is a full-time position where your expertise will directly impact the safety, reliability, and market acceptance of our cutting-edge AI infrastructure. What You’ll Be Working On: UL Standards Interpretation and Implementation: Thoroughly understand and interpret relevant UL891 standards and requirements applicable to our products. Execute inspection procedures and checklists to ensure ongoing compliance throughout the manufacturing process. UL Audit Preparation and Support: Assist in the preparation for and participate in UL audits, ensuring all necessary documentation and processes are in place and effectively followed. Address any findings and implement corrective actions as needed. Final Inspection Execution: Execute the final inspection stage for finished goods, ensuring products meet all quality standards, functional specifications, and UL891 requirements prior to shipment. Inspection Protocol Execution: Perform detailed final inspections according to established protocols, including visual checks, functional tests, and verification of labeling and documentation for UL compliance. Non-Conformance Management (Final Stage): Identify, document, and manage any non-conformances discovered during final inspection, and assist in implementing corrective actions to prevent recurrence. Quality Documentation (UL & Final): Maintain accurate and organized records of all test procedures, test results, calibration records, and non-conformance reports. Training and Guidance (UL & Final): Provide guidance to production personnel on UL requirements, final inspection procedures, and quality expectations. Cross-Functional Collaboration (UL Focus): Work closely with engineering and manufacturing to ensure products are designed and produced for UL compliance and manufacturability. Continuous Improvement (UL & Final): Identify opportunities for improving final inspection processes and enhancing UL compliance measures. Participate in continuous improvement initiatives to drive higher quality and efficiency. Other Duties: Undertake other quality-related tasks and projects as assigned to support overall operational efficiency and quality objectives. What You’ll Bring to the Team: Education: Minimum High School graduate or GED; Associate's or Bachelor's degree in a technical field or equivalent experience is preferred, and equivalent field experience will be considered. Experience: Minimum of five years’ experience in quality control roles within a manufacturing environment, with a significant focus on UL compliance and final product inspection. UL Standards Expertise: Demonstrated thorough understanding of relevant UL standards and certification processes. Experience working directly with UL representatives is a plus. Final Inspection Proficiency: Proven ability to execute comprehensive final inspection procedures for complex electro-mechanical assemblies. Technical Aptitude: Ability to interpret technical drawings, specifications, and schematics. Problem-Solving Skills: Strong analytical and problem-solving abilities to identify and resolve quality and compliance issues. Communication Skills: Excellent written and verbal communication skills to effectively interact with various teams and document findings. Organizational Skills: Exceptional attention to detail and strong organizational skills to manage documentation and inspection processes effectively. Computer Skills: Proficient in basic computer applications, including Google Suite (mail, drive, docs, sheets) and Microsoft Office (Word and Excel). Safety & Compliance: Strong commitment to safety regulations and quality standards. Willingness to comply with drug and alcohol program requirements as this position may be located in a safety-sensitive facility. Company Values Alignment: Your personal values resonate with Crusoe's core principles. Bonus Points: Experience with specific UL standards relevant to data center infrastructure or similar high-reliability equipment. Certifications related to quality control or UL compliance. Experience with implementing and maintaining quality management systems (e.g., ISO 9001). Familiarity with statistical process control (SPC) and other quality tools. Experience with root cause analysis and corrective action processes related to final inspection failures and UL non-compliance Benefits: Hybrid work schedule Industry competitive pay Restricted Stock Units in a fast growing, well-funded technology company Health insurance package options that include HDHP and PPO, vision, and dental for you and your dependents Employer contributions to HSA accounts Paid Parental Leave Paid life insurance, short-term and long-term disability Teladoc 401(k) with a 100% match up to 4% of salary Generous paid time off and holiday schedule Cell phone reimbursement Tuition reimbursement Subscription to the Calm app MetLife Legal Company paid commuter benefit; $200/month Compensation Range Compensation will be paid in the range of up to $23 -$30/hr + Bonus. Restricted Stock Units are included in all offers. Compensation to be determined by the applicants knowledge, education, and abilities, as well as internal equity and alignment with market data. Crusoe is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, disability, genetic information, pregnancy, citizenship, marital status, sex/gender, sexual preference/ orientation, gender identity, age, veteran status, national origin, or any other status protected by law or regulation.

Posted 5 days ago

C
Cox CommunicationsAtlanta, Georgia
Company Cox Automotive - USA Job Family Group Information Technology Job Profile Cyber Risk & Compliance Manager Management Level Manager - Non People Leader Flexible Work Option Hybrid - Ability to work remotely part of the week Travel % Yes, 15% of the time Work Shift Day Compensation Compensation includes a base salary of $108,800.00 - $181,400.00. The base salary may vary within the anticipated base pay range based on factors such as the ultimate location of the position and the selected candidate’s knowledge, skills, and abilities. Position may be eligible for additional compensation that may include an incentive program. Job Description The Security Compliance lead role involves implementing and managing compliance policies and procedures while fostering a culture of compliance across the organization. This leader will implement and our formal control framework and establish processes to recertify control ownership and operating effectiveness over time. Oversee internal and external security audits, ensuring remediation plans for identified issues are executed effectively as well as monitor emerging regulations and compliance trends to maintain up-to-date practices. Coordinate with regulatory bodies, auditors, and other stakeholders on security risk-related matters. This role will drive a culture of continuous improvement for security compliance practices, benchmark the organization’s compliance performance against industry peers, and foster innovation in security compliance to address emerging threats. Key Responsibilities Engages with Cox business leaders to ensure understanding and support of security compliance strategy, priorities and initiatives Coordinates effective roadmap development and governance for global initiatives related to security awareness, policy development, client and vendor compliance and overall process improvement Establish, maintain and communicate CAI security policies. Partner with cross-divisional counter parts to ensure alignment, where appropriate, across all Cox divisions. Develop and implement a robust internal control framework aligned with industry best practices (e.g., COSO framework). Design control activities to address identified risks and ensure effective monitoring of key processes. Serve as the liaison with External Auditors, Internal Audit, on all significant Compliance issues involving supported function/business/product and oversee implementation of related remediation. Manage all contractual security requirements requested by external parties and ensure that compliance obligations are understood, and requirements are documented. Prepare and present compliance reports to the engineering leaders and executive team Provide oversight and guidance over the assessment of broad complex issues, structures potential solutions and drive effective resolution with other senior stakeholders. Advise the businesses on an ongoing basis on new function/business/product initiatives, new products, business acquisitions, and client-related matters with respect to applicability of policies, resolution of potential red flags or other client/transaction-related compliance escalations. Manage a variety of compliance requirements including external attestations, regulatory requirements, interacting with clients, legal, stakeholders, and outside counsel as appropriate. Lead security requirements in obtaining and maintaining breach insurance coordinating with a variety of internal teams as well as our insurance brokers both domestically and internationally. Minimum Qualifications Bachelor’s degree in business, law, or a related field. At least 8 years of experience in compliance, risk management, or related areas, with a minimum of 7 years in a senior leadership role; The right candidate could also have a different combination such as a Master's degree in business, law or related field and 10 years of experience or a PhD and 7 years experience. Master’s degree preferred. Proactively builds, nurtures and maintains business-focused, long-term working relationships with partners inside and outside of the organization. Demonstrates flexibility when forming and adjusting partnerships to achieve broader goals. Shows willingness to work across boundaries to achieve outcomes addressing business, customer and partner goals and expectations. Demonstrated strong executive presence and communication skills. Direct oversight of managing external attestations such as SOC1/SOC2 Reports, as well as managing compliance with GLBA, PCI DSS, GDPR Direct experience managing and redlining contractual security requirements and interacting with legal. Direct experience with managing international compliance requirements in Europe Effective negotiation skills, a proactive and 'no surprises' approach in communicating issues and strength in sustaining independent views. Strong presentation and relationship management skills are essential Articulate and effective communicator, both orally and in writing, with an energetic, charismatic and approachable style. Candidates must have effective persuasion skills, the ability to work effectively at the highest levels of the organization, and will display highly effective networking and influencing skills Preferred Qualifications Ability to make strategic decisions, supervise complex programs, manage and educate highly skilled professionals, and influence other departments relating to security risk and control. Solid, pragmatic business acumen with a proven record of creatively solving problems and offering solutions. Consultative nature to work through controversial or complex topics to employees, leaders, and/or senior leadership. Ability to manage multiple complex projects while meeting all deadlines and manage leaders of teams to achieve optimal results. Develop strong and productive working environment with key stakeholders and collaborate closely with other Cox entities’ security teams to implement security best practices. Drug Testing To be employed in this role, you’ll need to clear a pre-employment drug test. Cox Automotive does not currently administer a pre-employment drug test for marijuana for this position. However, we are a drug-free workplace, so the possession, use or being under the influence of drugs illegal under federal or state law during work hours, on company property and/or in company vehicles is prohibited. Benefits The Company offers eligible employees the flexibility to take as much vacation with pay as they deem consistent with their duties, the company’s needs, and its obligations; seven paid holidays throughout the calendar year; and up to 160 hours of paid wellness annually for their own wellness or that of family members. Employees are also eligible for additional paid time off in the form of bereavement leave, time off to vote, jury duty leave, volunteer time off, military leave, and parental leave. About Us Through groundbreaking technology and a commitment to stellar experiences for drivers and dealers alike, Cox Automotive employees are transforming the way the world buys, owns, sells – or simply uses – cars. Cox Automotive employees get to work on iconic consumer brands like Autotrader and Kelley Blue Book and industry-leading dealer-facing companies like vAuto and Manheim, all while enjoying the people-centered atmosphere that is central to our life at Cox. Benefits of working at Cox may include health care insurance (medical, dental, vision), retirement planning (401(k)), and paid days off (sick leave, parental leave, flexible vacation/wellness days, and/or PTO). For more details on what benefits you may be offered, visit our benefits page. Cox is an Equal Employment Opportunity employer – All qualified applicants/employees will receive consideration for employment without regard to that individual’s age, race, color, religion or creed, national origin or ancestry, sex (including pregnancy), sexual orientation, gender, gender identity, physical or mental disability, veteran status, genetic information, ethnicity, citizenship, or any other characteristic protected by law. Cox provides reasonable accommodations when requested by a qualified applicant or employee with disability, unless such accommodations would cause an undue hardship. Applicants must currently be authorized to work in the United States for any employer without current or future sponsorship.

Posted 3 weeks ago

Senior Manager, Global Compliance Transparency-logo
StrykerNewark, New Jersey
Work Flexibility: Remote This Senior Manager, Global Compliance Transparency acts as a subject matter expert on global, federal, and state transparency regulations This senior manager will advise on leading practices for transparency reporting, supporting compliance officers on transparency matters, and partner with the Finance team responsible for reporting. The role will also enable data-informed decision-making by deriving insights from transparency submissions, and monitor for it for indicators of risk. This is a remote position within the US, and candidates located in the EST are preferred What you will do: Serve as a subject matter expert on global, federal, and state transparency regulations to support Compliance. Develop, execute, and oversee monitoring of transparency spend and data to identify emerging risks, outliers, and unusual patterns of behavior. Analyze transparency data to generate insights that inform compliance strategies and decision-making. Collaborate with the Finance team and other cross-functional stakeholders to design and implement transparency processes. Participate in cross-functional committees on transparency and act as a primary point of contact for Compliance Officers on transparency-related matters. Create and deliver training for Compliance Officers on transparency regulations and transfers of value. Coordinate with the Compliance function on updates to guidance, standards, and interactions with HCPs and transfers of value. Provide strategic input to enhance the Compliance program based on changes in laws, regulations, enforcement actions, industry standards, and business strategy. Maintain strong knowledge of the organization, business operations, and compliance metrics to inform strategy and goals. Promote a culture of continuous improvement, proposing program enhancements based on industry trends and best practices. Support annual Compliance Risk Assessment initiatives. Identify issues, engage appropriate stakeholders, perform root cause analysis, and implement effective solutions. Raise awareness of the compliance program, foster accountability for ethics and integrity, and champion a proactive approach focused on partnership, prevention, and risk mitigation. What you will need Required Bachelor's degree 10+ years of work experience 5+ Experience with US Federal and global transparency reporting requirements. experience with AdvaMed or PhRMA Code and other relevant compliance standards Knowledge of international, federal, and state transparency regulations (i.e., Sunshine Act) Possesses excellent communication, leadership, and influencing skills. Preferred Graduate degree or professional accreditation preferred (e.g., MBA, MS, JD, CFE, CCEP) Experience elements of effective compliance programs $115,600 - $245,800 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Travel Percentage: 10% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Posted 3 days ago

AFS Compliance Specialist II-logo
KBI BiopharmaDurham, North Carolina
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: Join a highly technical analytical team in a dynamic work environment as a member of the Analytical, Formulation and Stability (AFS) department and participate in contracted client analytical programs for monoclonal antibodies, recombinant proteins, and peptides. The AFS Compliance Specialist II will maintain a current understanding of United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations as they pertain to good practices in quality control and data documentation and will assist AFS management in coordinating measures to increase department compliance with and awareness of regulatory requirements, as well as internal processes/systems/procedures and right-first-time initiatives. One of the main focuses of this position is to coordinate, monitor, and track to completion the deliverables and activities associated with AFS continuous improvement projects to ensure timely completion and compliance with internal timelines, objectives, and processes/procedures. This individual will assist in the coordination of and/or participate in the development of new or revised procedures, department communications, training materials, and other deliverables associated with these projects, as able and as needed, in order to advance project completion. The AFS Compliance Specialist II will track and monitor AFS quality records (e.g., deviations, CAPAs, change controls, laboratory investigations, etc.) for on-time closure and trends and report this information regularly to department management. This position will provide support, as needed, for audit and inspection preparation activities, as well as ad-hoc requests from department management, including activities such as querying quality systems for requested information, summarizing queried results in presentable format, etc. The AFS Compliance Specialist II become familiar with internal processes, systems, and procedures as needed in order to provide assistance with tasks such as development of training material for new or updated processes/systems, preparation of communications regarding new and revised procedure highlights, and other technically administrative tasks. Position Responsibilities: Collaborate with department management to identify and clearly document required deliverables for continuous improvement projects and other types of special projects identified as being needed by the management team. Coordinate the assignment of deliverables to appropriate staff. Implement and/or use existing tools and processes to effectively coordinate, monitor, and track to on-time completion of the identified deliverables and activities. Obtain regular status updates from staff assigned to these deliverables, identify any roadblocks, and regularly communicate this information in a timely and effective format (e.g., meetings, presentation charts/graphs, formal email communications, etc.) to department management. Provide assistance and support to assigned staff in order to facilitate the on-time closure of these deliverables. Implement and/or use existing tools and processes to effectively coordinate, monitor, and track to on-time completion quality records assigned to the AFS department, including but not limited to CAPAs, deviations, laboratory investigations, change controls, periodic reviews, Calibration Alert Notifications, employee training, etc. Obtain regular status updates from staff assigned to these deliverables, identify any roadblocks and communicate this information in a timely and effective format to department management. Provide assistance and support to assigned staff in order to facilitate the closure of these records. Support audit and inspection preparation activities, as well as ad-hoc requests from department management as needed, including activities such as querying quality systems for requested information, summarizing queried results in presentable format, etc.. Become familiar with internal processes/systems/procedures and provide assistance, as needed, with tasks such as development of training material for new or updated processes/systems, preparation of communications regarding new and revised procedure highlights, and other technically administrative tasks Able to react to change productively and handle other essential tasks as assigned. Present independency in assigned tasks. Position Requirements: BS/BA and minimum 5 years of experience in CGMP regulated environment within biopharmaceuticals or equivalent, or MS/MA and minimum 3 years of experience in CGMP regulated environment within biopharmaceuticals or equivalent. Must have background in biopharmaceutical development, knowledge and understanding of cGMP standards and requirements, and have experience with regulatory compliance in biopharma industry. Proven ability to work independently and as a part of the team to resolve issues Strong decision making and problem-solving skills Demonstrated level of respect for individuals High level of integrity and personal responsibility Strong collaboration and team building skills; strong communication and interpersonal skills Strong orientation for quality and customer service Salary Range: $84,000-$115,500 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com . KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 30+ days ago

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MS Services GroupNew York, New York
Specific job responsibilities include: > Provide legal advice and support to business and compliance teams on issues related to AML, sanctions, and anti-corruption laws and regulations, including the USA PATRIOT Act, Bank Secrecy Act, OFAC/HMT regulations, U.S. Foreign Corrupt Practices Act (FCPA), UK Bribery Act, etc. > Review and advise on transactional due diligence pertaining to AML, sanctions, and anti-corruption > Draft and negotiate contractual provisions pertaining to AML, sanctions, and anti-corruption issues across all business lines > Inform and advise internal stakeholders on legal financial crime risks potentially impacting the Firm's clients, transactions, and/or business practices > Review, interpret, and advise on relevant laws and industry best practices pertaining to AML, sanctions, and anti-corruption > Advise as to the relevance of trade restrictions such as export controls and customs requirements for the Firm's business > Develop content for and deliver specialized training to relevant internal audiences concerning AML, sanctions, and anti-corruption legal issues > Liaise and coordinate within GFC and with key stakeholders across the Firm, including Legal, Compliance, Regulatory Relations, and Risk, to ensure appropriate execution of the Firm's enterprise-wide financial crimes prevention program > Assist and work with in-house litigators and outside counsel as necessary, in representing the Firm before legal and regulatory authorities in matters related to AML, sanctions, and anti-corruption legal issues > Assist with responding to regulatory exams and other inquiries, and internal audits, including overseeing document productions > Provide support for special projects arising from the administration of the GFC program > Juris Doctor (JD) (or equivalent) with strong academic credentials > 10+ years of relevant, post-qualification experience, preferably at a large/complex financial institution, law firm, or government/regulatory body > Detailed understanding of the laws, rules, and regulations pertaining to AML, sanctions, and anti-corruption > Deep subject matter expertise and experience in sanctions legal matters > Ability to understand and assess a wide variety of complex commercial transactions > Highly motivated self-starter able to work independently while collaborating and coordinating as part of a global program > Strong analytical and problem-solving skills and the ability to provide viable solutions in a time-sensitive environment > Exceptional written and verbal communications skills, attention to detail, and effective time management > Strong project management skills > Sound judgment and an ability to appropriately escalate issues internally > Proven ability to handle highly confidential information professionally and with appropriate discretion > Outstanding interpersonal skills and team-player attitude > Proficiency with MS Word, Excel, PowerPoint, and Outlook Skills Desired: > Strong understanding of financial markets and banking transactions > Familiarity with export controls laws, customs laws, and other trade restrictions WHAT YOU CAN EXPECT FROM MORGAN STANLEY: We are committed to maintaining the first-class service and high standard of excellence that have defined Morgan Stanley for over 89 years. Our values - putting clients first, doing the right thing, leading with exceptional ideas, committing to diversity and inclusion, and giving back - aren’t just beliefs, they guide the decisions we make every day to do what's best for our clients, communities and more than 80,000 employees in 1,200 offices across 42 countries. At Morgan Stanley, you’ll find an opportunity to work alongside the best and the brightest, in an environment where you are supported and empowered. Our teams are relentless collaborators and creative thinkers, fueled by their diverse backgrounds and experiences. We are proud to support our employees and their families at every point along their work-life journey, offering some of the most attractive and comprehensive employee benefits and perks in the industry. There’s also ample opportunity to move about the business for those who show passion and grit in their work. Morgan Stanley's goal is to build and maintain a workforce that is diverse in experience and background but uniform in reflecting our standards of integrity and excellence. Consequently, our recruiting efforts reflect our desire to attract and retain the best and brightest from all talent pools. We want to be the first choice for prospective employees. It is the policy of the Firm to ensure equal employment opportunity without discrimination or harassment on the basis of race, color, religion, creed, age, sex, sex stereotype, gender, gender identity or expression, transgender, sexual orientation, national origin, citizenship, disability, marital and civil partnership/union status, pregnancy, veteran or military service status, genetic information, or any other characteristic protected by law. Morgan Stanley is an equal opportunity employer committed to diversifying its workforce (M/F/Disability/Vet). Expected base pay rates for the role will be between $160,000.00 and $250,000.00 per year at the commencement of employment. However, base pay if hired will be determined on an individualized basis and is only part of the total compensation package, which, depending on the position, may also include commission earnings, incentive compensation, discretionary bonuses, other short and long-term incentive packages, and other Morgan Stanley sponsored benefit programs. Morgan Stanley's goal is to build and maintain a workforce that is diverse in experience and background but uniform in reflecting our standards of integrity and excellence. Consequently, our recruiting efforts reflect our desire to attract and retain the best and brightest from all talent pools. We want to be the first choice for prospective employees. It is the policy of the Firm to ensure equal employment opportunity without discrimination or harassment on the basis of race, color, religion, creed, age, sex, sex stereotype, gender, gender identity or expression, transgender, sexual orientation, national origin, citizenship, disability, marital and civil partnership/union status, pregnancy, veteran or military service status, genetic information, or any other characteristic protected by law. Morgan Stanley is an equal opportunity employer committed to diversifying its workforce (M/F/Disability/Vet).

Posted 1 week ago

Sr. Advisor, Compliance – TriState Capital Bank-logo
Raymond JamesPittsburgh, Pennsylvania
Job Description Summary Monitor and analyze the organization's operational risk exposure, and contribute to the development of operational risk policies. Analyze existing processes, procedures and systems and advise on improvements. Job Description TriState Capital Bank is an independent chartered bank subsidiary of Raymond James. Headquartered in Pittsburgh, PA, TriState Capital Bank provides premier private banking, commercial banking, and treasury management products and services to corporate, institutional, and high-net-worth (HNW) clients. Job Summary Under general supervision, uses extensive knowledge and skills obtained through experience, specialized training and/or certification in the banking industry to ensure compliance with all banking rules and regulations. Coordinates compliance functions, guides compliance efforts, and act as a liaison between functional areas. Leads large or multiple projects with significant scope and impact. Works independently on difficult assignments that are broad in nature and that require originality and ingenuity with appreciable latitude for unreviewed actions or decisions. Provides comprehensive solutions to complex problems. Maintains extensive contact with internal customers to identify, research, analyze and resolve complex issues. Essential Duties and Responsibilities Oversees compliance program for an assigned business entity to ensure compliance processes and procedures are integrated and aligned with business processes. Directs adjustments to existing programs, policies, and procedures, as required. Ensures that compliance activities are commensurate with the level of risk being mitigated. Provides escalated support and guidance to compliance efforts in assigned business entity. Informs appropriate Senior Management about issues that may involve rule violations or potential liability. Assists Management to implement adequate controls and quality assurance processes to detect and address potential compliance problems. Research compliance issues. Alerts Senior Management of current regulatory issues. Researches, interprets, and translates regulatory rules and regulations for Senior Management. Monitors exception and other internal reports for employee adherence with rules and regulations. Advises Senior Compliance Management on issues that involve possible rule violations and potential liability. Addresses sensitive compliance issues with Management in assigned functional area. Participates in corporate policy discussions related to compliance. Reviews documentation related to compliance issues for validity and alignment with organizational policies. Prepares and delivers written and oral presentations to senior management. May coordinate and/or oversee responses to regulatory agency inquiries. Develops compliance training programs in conjunction with other compliance activities, as well as maintains training records. Reports compliance program status and activities to compliance and business management personnel. Manages relevant external examinations, ensuring that requested information and reports are provided. Prepares and delivers written and oral presentations to Management. Performs other duties and responsibilities as assigned. Knowledge, Skills, and Abilities Knowledge of: Concepts, practices, and procedures of the banking compliance reviews. Rules and regulations of the Federal Deposit Insurance Corporation (FDIC); Office of the Comptroller of the Currency (OCC); Federal Financial Institutions Examination Council (FFIEC); Federal Reserve System; and state banking regulatory agencies. Principles of banking and finance operations. Financial markets and products. Skill in: Overseeing compliance programs. Integrating and aligning compliance processes and procedures with business processes. Coordinating complex compliance activities. Providing support and guidance for compliance efforts. Identifying and implementing controls and quality assurance processes. Reviewing materials for compliance with rules and regulations. Researching compliance issues. Developing compliance training programs. Gathering information and preparing oral and written reports. Preparing and delivers written and oral presentations. Investigating relevant changes to the regulatory landscape Making rule-based and analytical decisions. Operating standard office equipment and using required software applications. Ability to: Partner with other functional areas to accomplish objectives. Facilitate meetings, ensuring that all viewpoints, ideas, and problems are addressed. Attend to detail while maintaining a big picture orientation. Gather information, identify linkages and trends, and apply findings to assignments. Interpret and apply securities and/or banking regulations and identify and recommend policy and procedural changes as appropriate. Work under pressure on multiple tasks concurrently and meet deadlines in a fast-paced work environment with frequent interruptions and changing priorities. Use appropriate interpersonal styles and communicate effectively, both orally and writing, with all organizational levels. Work independently as well as collaboratively within a team environment. Provide a high level of customer service. Establish and maintain effective working relationships at all levels of the organization. Maintain confidentiality. Maintain currency in banking industry rules and regulations and best practices in compliance. Educational/Previous Experience Requirements Bachelor’s degree (B.A. /B.S.) and a minimum of three (3) years of experience in Compliance and/or the financial services industry preferred. Any equivalent combination of experience, education, and/or training approved by Human Resources. Licenses/Certifications None Required. Additional licenses/certifications demonstrating the candidate’s knowledge/expertise in industry regulation and concepts preferred. Education Bachelor’s: Accounting, Bachelor’s: Actuarial Science, Bachelor’s: Applied Mathematics Work Experience Manager Experience - 3 to 6 years Certifications Securities Industry Essentials Exam (SIE) - Financial Industry Regulatory Authority (FINRA) Travel Workstyle Resident At Raymond James our associates use five guiding behaviors (Develop, Collaborate, Decide, Deliver, Improve) to deliver on the firm's core values of client-first, integrity, independence and a conservative, long-term view. We expect our associates at all levels to: • Grow professionally and inspire others to do the same • Work with and through others to achieve desired outcomes • Make prompt, pragmatic choices and act with the client in mind • Take ownership and hold themselves and others accountable for delivering results that matter • Contribute to the continuous evolution of the firm At Raymond James – as part of our people-first culture, we honor, value, and respect the uniqueness, experiences, and backgrounds of all of our Associates. When associates bring their best authentic selves, our organization, clients, and communities thrive. The Company is an equal opportunity employer and makes all employment decisions on the basis of merit and business needs.

Posted 4 days ago

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Genmab USPrinceton, Florida
At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! The Role The Director, Medical Affairs Training & Development, will work closely with Medical Affairs Capabilities colleagues and with the Medical Affairs Strategy Leadership Team to develop and maintain all Medical Affairs training curricula both in terms of technical as well as soft skills. The candidate in this position will demonstrate a thorough understanding of the medical training needs for both office-based and field-based associates. This role will create an environment of accountability by communicating expectations, timelines and disseminating information for training and certifications. The impact this role will have on the organization includes the following: Effectively communicate relevant & fair balanced scientific information about Genmab products; seek feedback from MSLs, MSL and Medical Affairs Leadership to ensure needs are being met; leverage a variety of communication channels to provide training In collaboration with providers ensure the development of competences aligned with industry standards as it relates to soft skills, business skills, and emotional intelligence Consistently support senior management decisions and train colleagues and new hires to think strategically to support decisions made by Medical Affairs leadership Increase the proficiency of the Medical Affairs colleagues regarding clinical data / disease states, pipeline, as well as competitor data ultimately fostering scientific exchange with key HCPs and KOLs Partner with Compliance colleagues to develop and roll out training to internal clients, partners, and stakeholders on key compliance policies and procedures Responsibilities Provide strategic oversight to training around Genmab’s assets and pipeline in line with changing organizational and industry prerogatives Collaborate with Medical Affairs leadership for departmental strategic planning and operational excellence and execution across all Medical Affairs. Develop and maintain FMA Onboarding activities, collaborating with FMA leadership, inclusive of 90-day training plan/schedule, scientific training and certification Support new hire medical affairs onboarding at the direction of the hiring manager Facilitate Medical Affairs continuing education (disease states and scientific data), including treatment landscape training and certification. Utilize MASLs, FMA Leads at discretion as appropriate Establish training documentation for Medical Affairs Work closely with Medical Affairs Leadership Team to identify training needs and plan for the most appropriate educational programs. Manage project budget by forecasting & prioritizing projects within established training plan. Develop and monitor metrics and KPIs to assess effectiveness of educational activities. Provide senior management with regular updates on these metrics also highlighting actionable trends and patterns Work closely with Medical Information and Medical Communication colleagues to determine training needs for approved slide decks required for scientific exchange and answering unsolicited questions Establish and maintain Medical Affairs Developmental training curriculum Collaborate with US Market Training and Excellence on scientific education and compliant communication across functions. Collaborate with Market Access leadership and US Market training to ensure functional specific training exists for the Market Access and HEOL teams that meets stakeholder needs in a compliant manner. Coordinate support for Sales/Commercial training at district, regional and national sales meetings/POAs and launch meetings by FMA colleagues Member of Genmab Training Community, which leads set up of systems for skill-building across teams within Genmab Work closely with FMA, MASLs to determine strategic importance of medical data presented at congresses / medical meetings to facilitate internal training on key data Oversee annual Medical Affairs Training budget and work with allocated resources, including accurate maintenance of contracts and invoices Effectively manage external collaborations to enhance training initiatives. Working with the Compliance team to develop and roll out training to internal clients, partners, and stakeholders on key compliance policies and procedures Reviewing proposed engagements with US healthcare related stakeholders to identify any compliance risk areas and to suggest mitigation strategies, as appropriate. Develop functional a Training Plan as part of Medical Affairs Annual Medical Planning process. Develop asset-specific plans inclusive of launch support. Reviewing business materials requiring compliance operational input and advising internal clients, partners, and stakeholders on appropriate strategies, plans and tactics Requirements Advanced degree (MD, PharmD, PhD,) in medical/biosciences 10+ years of experience in industry settings, in pharma/biotech industry Oncology disease management knowledge required Minimum of 3 years’ experience in training, medical excellence or related and relevant function Candidates without an advanced degree are required to have at least 3 years of industry MSL experience in the therapeutic area, and 7 years overall related experience. Strong broad based scientific and pharmaceutical knowledge, as well as excellent presentation and teaching skills. Strong overall written and verbal communication skills. Proven ability to train professionals on soft skills, strategic thinking, and business acumen Ability to efficiently manage time and priorities. Strong leadership skills and the ability to compile and disseminate information to others in a cohesive fashion to assure a clear understanding of project status and direction. Solid understanding of drug development and life-cycle development of a product. Ability to motivate and teach team members without a direct reporting relationship. Demonstrated ability to think critically, analyze situations and achieve goals. Excellent computer skills including power point, word & excel. Ability to travel as needed to Conference and internal meetings, up to 10- 20% of the time Additional Job Description Provide inputs to medical affairs strategy from CoE perspective (training & compliance, project management, medical education, grants & sponsorships) Proactively propose and drive high-impact initiatives within CoE with cross-functional teams Provide expert guidance; conduct troubleshooting for complex issues and bottlenecks across projects; propose systemic changes to prevent recurrence Establish systems for accurate tracking and reporting of CoE objectives (e.g. training budgets and effectiveness of educational programs, grant outcomes, vendor metrics, compliance metrics, project/program dashboards) Foster and drive delivery and innovation within CoE based on expertise Customize and deliver communication around complex interconnected CoE outcomes to diverse internal and external audiences with executive presence Proactively engage and collaborate, as a thought leader, with experts, organizations, and scientific stakeholders, through global forums/initiatives to build organizational reputation and credibility Lead/support set-up of systems for skill-building across teams within area For US based candidates, the proposed salary band for this position is as follows: $203,840.00---$305,760.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About You You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X . Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com) . Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Posted 4 days ago

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X-RiteorporatedGrand Rapids, Michigan
Imagine yourself… Growing your expertise and expanding your skillset with every project. Thriving in a supportive team environment that inspires you to strive for excellence. Joining a colorful company with a proven track record of success and an exciting future ahead. It’s all possible with a role at X-Rite Pantone, the global leaders in color science and technology. X-Rite Pantone, a Veralto company, provides complete end-to-end color management solutions for clients in every industry where color matters. At X-Rite Pantone, you’ll deftly blend the art and science of color to help customers inspire, select, measure, formulate, communicate and match color so that users get color right the first time, every time. And along the way, you’ll build a vibrant career through rich skill-building opportunities, on-the-job learning, and coaching and training that supports your continued development and growth. Reporting to the Senior Director of Global Engineering, Quality & Compliance,the Global Regulatory Compliance Manager will oversee and manage all regulatory compliance activities related to product safety and environmental compliance across the global markets we serve. This role is critical in ensuring that our products meet relevant regulations and standards, enabling global market access while maintaining the company’s reputation for safety and sustainability. In this role, a typical day will look like: Lead and manage the global regulatory compliance program and team, ensuring all products meet international and local safety and environmental regulations. Monitor and interpret global regulatory requirements, including but not limited to product safety (e.g., UL/ETL, CE, UK CA, IEC, etc.) and environmental compliance (e.g., RoHS, REACH, WEEE, etc.). Develop and implement strategies to ensure ongoing compliance with new and changing regulations in all regions where the company operates. Collaborate with cross-functional teams, including engineering, quality, product management, legal, and operations, to ensure compliance considerations are integrated into product development and sustaining engineering processes. Oversee the preparation and submission of regulatory filings, documentation, and certifications required for product approvals and market entry. Conduct internal audits to ensure compliance with regulatory standards and lead external audits and inspections as required. Manage the day-to-day activities of the internal accredited test lab. The essential requirements of the job include: Bachelor’s degree in engineering, Environmental Science, or a related field. A Master’s degree or certifications in regulatory affairs is a plus.; applicable to the above stated expectations for the manufacturing of electronic and electro-mechanical products. Minimum of 5-7 years of experience in regulatory compliance, preferably within the electrical and/or electro-mechanical manufacturing industry. Extensive knowledge of global product safety standards and environmental regulations (e.g., CE, UL, ETL, RoHS, REACH, etc.). Proven experience managing compliance across multiple jurisdictions, including North America, Europe, and Asia-Pacific regions. Strong project management skills with the ability to lead cross-functional teams and manage multiple projects simultaneously. Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and regions. X-Rite Pantone is proud to part of the Product Quality & Innovation segment of Veralto (NYSE: VLTO), a $5B global leader dedicated to ensuring access to clean water, safe food and medicine, and trusted essential goods. When you join Veralto’s vibrant global network of 16,000 associates, you join a unique culture and work environment where purpose meets possibility : where the work you do has an everyday impact on the resources and essentials we all rely on, and where you’ll have valuable opportunities to deepen your skillset, pursue your ambitions, and grow your career. Together, we’re Safeguarding the World’s Most Vital Resources™—and building rewarding careers along the way. US ONLY : The below range reflects the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future. An associate’s position within the salary range will be based on several factors, including, but not limited to, relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, shift, travel requirements, sales or revenue-based metrics, any collective bargaining agreements, and business or organizational needs. The compensation range for this role is $99,000 - $121,000 USD per year. This job is also eligible for Bonus Pay. We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. US residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Veralto Corporation and all Veralto Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. The EEO posters are available here . We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@veralto.com to request accommodation. Unsolicited Assistance We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at any of the Veralto companies , in any form without a valid, signed search agreement in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Veralto and its companies. No fee will be paid in the event the candidate is hired by Veralto and its companies because of the unsolicited referral.

Posted 6 days ago

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Abbott Diabetes CareAlameda, California
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Sr. Quality Compliance Specialist Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity We are seeking a detail-oriented and proactive Compliance Specialist to join our Compliance team. This role is critical in maintaining a state of continuous inspection readiness and ensuring compliance with applicable regulatory requirements, including ISO 13485 and MDSAP. The Compliance Specialist will lead and support internal and external audits readiness activities, manage audit-related documentation, and drive quality system improvements. What You'll Work On Maintain and continuously improve the inspection readiness program to ensure the site is always prepared for regulatory and internal audits. Coordinate and support internal audits, including planning, execution, reporting, and follow-up on corrective actions. Serve as a support during external audits (e.g., Notified Bodies, FDA, Corporate), including logistics, documentation, and auditee coaching. Monitor and ensure compliance with applicable regulatory standards applicable to ADC (ISO 13485, MDSAP, 21 CFR Part 820, etc.). Maintain audit schedules, records, and metrics; track and trend audit findings to identify systemic issues. Collaborate with cross-functional teams to ensure timely and effective CAPA implementation related to audit findings. Support the development and delivery of training on audit readiness and compliance topics. Participate in quality system improvement initiatives and support regulatory submissions as needed. Required Qualifications Bachelor’s degree in a scientific, engineering, or quality-related field. 5+ years of experience in quality assurance or regulatory compliance in the medical device industry. Strong knowledge of ISO 13485, MDSAP, and other applicable regulations. Preferred Qualifications: Experience supporting or leading audits (internal and external). Excellent organizational, communication, and problem-solving skills. Ability to work independently and collaboratively in a fast-paced environment Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott , and on Twitter @AbbottNews. Divisional Information Medical Devices General Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Diabetes We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. The base pay for this position is $86,700.00 – $173,300.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: ADC Diabetes Care LOCATION: United States > Alameda : 1360-1380 South Loop Road ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Posted 1 week ago

Security, Risk and Compliance Consultant-logo
SEIBoston, Massachusetts
WHO WE LOOK FOR An SEI-er is a master communicator and active listener who understands how to navigate an audience. Self-aware, almost to a fault, SEI-ers keenly understand how to adjust their support and problem solving based on the situation. Following a logical, fact-based approach, SEI-ers possess the superior ability to see correlations others may not, ask the right questions and drive solutions. As super-connectors, they connect not only people, but data, trends and experiences. Mature, humble, and genuine, SEI-ers frequently go above and beyond for both their clients and their colleagues. SEI-ers are ethical and trustworthy individuals who consistently and repeatedly follow through, and hold true to their values in difficult situations. SEI-ers have an insatiable curiosity and love to learn. These individuals are commonly tech savvy and early adopters. Their passion for learning is infectious and excites others. As every project is different, an SEI-er must be adaptable and comfortable with unexpected situations. SEI-ers define ambition differently. They are authentic, low-maintenance individuals who truly enjoy one another- they like to hang out with colleagues outside of work, collaborate and hold one another accountable. SEI-ers enjoy working with genuine, thoughtful folks who want to steer clear of the traditional grind and share the joy of day-to-day life and activities with colleagues, friends, and family. WHAT WE DO Our Security, Risk and Compliance consultants work with clients at all levels of the organization, from the C-suite to the shop floor, helping them to deliver on their most strategic initiatives. We’re known for making realistic, data-driven decisions that deliver value in tangible ways to our clients. Our clients ask for us on projects that require a superior combination of technical and business capabilities, people and management skills, and a collaborative mindset. We excel in understanding complex programs and strategic initiatives and breaking them into actionable pieces. We are actively looking for professionals in the following areas: Compliance Information Security Risk Management Data Privacy The ideal candidate’s experience may include but is not limited to the following: Management or participation in Cybersecurity, Information Security, Risk, Compliance and/or Data Privacy Programs or Projects Sample projects/programs could include but are not limited to: Compliance framework mapping and implementation, Regulatory mapping and implementation Audit, risk or regulatory remediation management, Readiness for new laws and regulations, Risk, Compliance or Information Security risk reporting and monitoring Creation of roadmaps to mature or advance Risk, Compliance or Information Security Strategies/Programs/Controls Design and enablement of cyber controls functions and processes Change management related to regulatory adoption or compliance changes Audit or certification readiness Familiarity or direct experience with GRC/Cybersecurity solutions, tools and technologies Control design or maturation for high-demand technical areas such as ERP, Identity and Access Management, Business Continuity and Resiliency, Cloud Knowledge of and/or application of industry specific regulations, laws, and standards such as the EU-GDPR, CCPA/CPRA, HIPAA, PCI Knowledge of and/or application of compliance and security frameworks and standards such as COSO, NIST, ISO Management of regulatory, internal or external audits, or experience as an auditor Projects or roles requiring coordination across lines of defense working with technical, business, compliance, risk and audit teams to deliver solutions Work or projects with military or federal government agencies in Risk, Compliance or Information Security/Cyber Security sectors Certifications: CIPP, CRCM, CRM, ARM, CISSP, CISM QUALIFICATIONS Required- Alignment to our core values: Excellence, Participation, Integrity, and Collaboration Hungry, Humble, Smart Demonstrated business and technology acumen Strong written and verbal communication skills Understanding and experience solving real business problems Proven track record of delivering results Experience working with and/or leading a team Ability to work across industries, roles, functions & technologies Authorization for permanent employment in the United States (this position is not eligible for immigration sponsorship) Preferred- Bachelor’s degree 8+ years professional experience Experience across our service offerings Systems Evolution, Inc. (SEI) is an equal opportunity employer (EOE) and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law

Posted 30+ days ago

Security Compliance Engineer-logo
CartesiaSan Francisco, California
About Cartesia Our mission is to build the next generation of AI: ubiquitous, interactive intelligence that runs wherever you are. Today, not even the best models can continuously process and reason over a year-long stream of audio, video and text—1B text tokens, 10B audio tokens and 1T video tokens—let alone do this on-device. We're pioneering the model architectures that will make this possible. Our founding team met as PhDs at the Stanford AI Lab, where we invented State Space Models or SSMs, a new primitive for training efficient, large-scale foundation models. Our team combines deep expertise in model innovation and systems engineering paired with a design-minded product engineering team to build and ship cutting edge models and experiences. We're funded by leading investors at Index Ventures and Lightspeed Venture Partners, along with Factory, Conviction, A Star, General Catalyst, SV Angel, Databricks and others. We're fortunate to have the support of many amazing advisors, and 90+ angels across many industries, including the world's foremost experts in AI. Role Responsibilities We are seeking a Security Compliance Engineer with DevOps and Cloud experience to enhance our engineering team. This role combines security, compliance, and DevSecOps to ensure our infrastructure is secure, compliant, and efficiently managed. As a key member of the Information Security group, you will maintain and enhance our established compliance programs while driving security excellence across our engineering organization. This role combines hands-on technical and deep compliance expertise to ensure continued customer trust as we scale . What You'll Do: Design, implement, and work with other engineering teams to operate security tools and programs across the organization including access control & workflows, vulnerability management, and detection/response systems. Implement, configure security tools and fast learning of new security technologies in cloud infrastructure and product security. Maintain SOC 2 Type II, HIPAA, GDPR, ISO 27001, and PCI DSS compliance programs including annual audits and remediation Partner with business operations team to conduct security assessments of vendors and complete customer security questionnaires Build and maintain security policies, procedures, and incident response protocols Lead cross-functional security initiatives including access management, vulnerability remediation, and security training Create dashboards and reports to track security metrics and compliance status What You'll Bring 4+ years of hands-on security and compliance experience at B2B SaaS companies Proven track record collaborating with engineering teams on security architecture and controls Exceptional communication skills for both technical and business stakeholders Track record of building or maintaining compliance programs from the ground up Ability to execute in fast-paced startup environments Nice-to-Haves Early-stage startup experience (Series A-C preferred) Security certifications (CISSP, CISA, or equivalent) Experience with GRC tools (Vanta, Drata, OneTrust) Knowledge of cloud security (AWS, GCP, Azure) Understanding of DevSecOps practices and security automation Our culture 🏢 We’re an in-person team based out of San Francisco. We love being in the office, hanging out together and learning from each other everyday. 🚢 We ship fast. All of our work is novel and cutting edge, and execution speed is paramount. We have a high bar, and we don’t sacrifice quality and design along the way. 🤝 We support each other. We have an open and inclusive culture that’s focused on giving everyone the resources they need to succeed. Our perks 🍽 Lunch, dinner and snacks at the office. 🏥 Fully covered medical, dental, and vision insurance for employees. 🏦 401(k). ✈️ Relocation and immigration support. 🦖 Your own personal Yoshi.

Posted 4 weeks ago

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Leidos QTC Health ServicesPhiladelphia, Pennsylvania
Do you crave a career that truly makes an impact in people’s lives? Do you thrive on problem-solving and finding solutions? Join a dedicated, tight-knit team that creates an immediate and meaningful impact every day Leidos QTC Health Services is seeking a Compliance Outreach Coordinator on our OSHA/ADA team. You will support our organization’s regulatory compliance efforts related to OSHA (Occupational Safety and Health Administration) and ADA (Americans with Disabilities Act) standards. This role is primarily responsible for initiating and managing outreach efforts—via phone and email—to locations identified as non-compliant, ensuring they receive and act on corrective action items promptly and effectively. *This job is primarily remote with travel to Leidos QTC Health Services clinics as needed. Primary Responsibilities: Conduct outreach (phone calls and emails) to internal or external site contacts regarding identified OSHA and ADA compliance issues. Communicate clearly and professionally about specific corrective action items required to address violations or deficiencies. Provide support and guidance to site personnel on next steps, timelines, and documentation requirements for compliance. Maintain detailed records of all outreach communications and updates in compliance tracking systems. Coordinate with Compliance Coordinators and/or leadership to ensure alignment on action items and regulatory standards. Follow up on overdue or incomplete corrective actions and escalate issues when necessary. Assist in preparing summary reports on outreach effectiveness, compliance trends, and recurring issues. Stay up to date on OSHA and ADA regulations relevant to the organization’s operations. Support process improvements for compliance outreach and tracking procedures. May be required to travel to also support with site inspections, audits and other meetings as determined by leadership Perform other duties and responsibilities as assigned Required Qualifications: High school diploma or equivalent required 1-3 years of experience in compliance, regulatory affairs, customer service, or related administrative roles Familiarity with OSHA and ADA regulations strongly preferred Strong verbal and written communication skills High attention to detail and accuracy Must possess a Valid U. S. Driver’s License Proficient in Microsoft Office Suite and compliance tracking software (e.g., Smart Sheets, Salesforce, or similar tools) Must be able to successfully pass National Agency Check with Inquiries (NACI) background investigation Preferred Qualifications: Travel Flexibility: Willingness to travel approximately 5% of the time or as needed. Communication Skills: Exceptional written, verbal, and visual communication abilities. OSHA ADA Knowledge: Understanding of OSHA ADA regulations. Exceptional organization and project management skills Excellent computer and analytical skills About Leidos QTC Health Services Leidos QTC Health Services collaborates closely with government and non-government customers to address current and future program needs within the health services domain. We specialize in disability-focused medical examinations, independent medical exams and review services, occupational health services, diagnostic testing, and case management solutions. As innovators, we focus on advancing technologies that improve service delivery, with a particular emphasis on enhancing accessibility for examinees in rural communities. With a proven track record of continuous improvement and steady growth, we now handle over 2 million appointments annually. Visit www.qtcm.com for more information. Compensation and Benefits Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. As a result, we offer meaningful and engaging careers to support you and your career goals, all while nurturing a healthy work-life balance. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here.

Posted 5 days ago

Facilities Compliance Specialist II-logo
KBI BiopharmaDurham, North Carolina
Job Summary : The Facilities Compliance Specialist II supports the Facilities Engineering Department as a part of a rapidly expanding GMP Contract Manufacturing Operation. The Specialist will need to produce high-quality documentation that contributes to the overall success of our operations. The Specialist will be responsible for the completion of Facilities Engineering Change Controls, CAPAs, Deviations, Risk Assessments, SOPs, and other quality documentation. The candidate will exercise good communicative and collaborative skills to work with department SMEs and the site Quality and Regulatory organizations. The candidate will ensure that department compliance measures are maintained, all documentation meets regulatory requirements, and is completed according the determined target timelines. The candidate should have experience in biotechnology manufacturing and quality system writing. The candidate may also lead or act as a team member for special projects as determined by the Department Head in support of continued improvement of department goals and initiatives. Job Responsibilities: Support CAPAs, Change Control, Deviation, Risk Analysis, Root Cause Analysis and other Quality Systems. Support Engineering, Validation, Maintenance, and Metrology in the develop and revision of Standard Operating Procedures (SOPs), completion of periodic reviews, and other quality documentation. Demonstrate strong technical skills. Provide technical assistance to area supervisors or manages to solve complex problems, Exercise judgement in developing practices, techniques, and evaluation criteria for obtaining results Assist in generation of department quality metrics and track the status of active records. Complete special projects and other assigned duties to achieve department goals. Requirements: Education: / Skills: BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Engineering, etc. or equivalent combination of education and experience; 3-5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices including: QA, QC, Validation, Manufacturing, Maintenance, or Engineering. Knowledge of the facilities operation typical to the biotechnology/pharmaceutical industry. Worked closely with Engineering, Validation, or Maintenance. Language Ability: Ability to read and interpret English documents such as safety rules, operating and maintenance instruction, procedure manuals, batch and production records. Ability to write routine reports and correspondence Ability to speak effectively before internal groups and employees Good deductive and inductive critical thinking skills required. Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Strong time management skills and an ability to multitask in a face paced environment. Ability to deliver high quality documentation paying attention to detail. Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures. Math Ability: Ability to add, subtracts, multiply, and divides in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Computer and Equipment Skills: Knowledge of and experience using Microsoft Office: Word, Excel, Power Point, Visio Experience. Knowledge of and experience using a computer, telephone, copy machine, and fax machine Range: $74,000.00 / yr. - $102,300.00 / yr. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 30+ days ago

Manager SCM Compliance & Small Business Liaison-logo
Austal USAMobile, Alabama
REPORTS TO: VP, Supply Chain Management AUTHORITIES / RESPONSIBILITIES: Compliance: Manages the SCM compliance function of Austal USA, and is the point of contact for Compliance for the department regarding the Contractor Purchasing System Review (CPSR), Material Management and Accounting System (MMAS) and the department ISO 9001 compliance Monitors and ensures all records and documents are maintained according to supply chain best practices, Government regulations, and Company policies and procedures Conducts routine compliance reviews on procurement files to document ongoing operational quality, and submit quarterly reports on risks and recommendations Liaises with various government agencies (predominately DCAA, DCMA and SUPSHIP) as well as external audit agencies and other financial consulting organizations Prepares responses to DCAA or other government agency audit requests and reports as well as maintains internal management review& reporting Follow up on reviews to verify that corrective actions have been implemented Manages personnel whose responsibilities include SCM compliance and procedural activities Works with management to identify potential government and risk compliance problems Develop and facilitate process improvements derived by compliance or through lean development to enhance business capability Supports the development of templates and other tools that support compliant purchasing and supply chain actions Coordinates compliance training to address any compliance issues Support the Estimating Business System initiative in response to RFP or RFQ requirements to ensure subcontract prices are reasonable based on review and analysis, in accordance with DFARs Cost Estimating System Requirements Small Business: Develop and promote Austal’s policy that demonstrate support for awarding contracts and subcontracts to small businesses including HUB Zone small business, small disadvantaged business, women-owned small business, veteran- owned small business, and service-disabled veteran-owned small business concerns Manage and ensure all aspects of the Austal USA Small Business Program are followed to the maximum practical extent such as the following: Developing and maintaining bidders' lists of small businesses and other socio- economic categories from all possible sources Ensuring that Austal’s subcontract Requests For Proposals (RFPs) and Request for Quotes (RFQs) are designed to permit the maximum possible participation of small businesses Participating in the establishment and maintenance of contract and subcontract records in regards to small business concerns Attending, or advising Austal personnel of their need to attend, outreach events, business opportunity workshops, Minority Business Enterprise Seminars, and Trade Fairs Providing counseling directly or indirectly to small businesses including subcontracting opportunities and how to prepare bids to respond to Austal requests Confirming the small business type and/or classification represented by bidders Coordinating Austal’s small business activities with the U.S. Government and/or other customer Small Business personnel on a continual basis to ensure Austal remains compliant and aware of changing small business requirements between audits Working in concert with Business Development, Contracts and Cost/Price personnel throughout the proposal development lifecycle to comment or advise on small business related issues and impacts Ensuring that necessary flow down clauses in are notified to Supply Chain for inclusion in RFP’s, RFQ’s and any follow-on purchase orders QUALIFICATIONS / KNOWLEDGE / EXPERIENCE: Bachelor’s degree in Business, Supply Chain, Material Management or related field preferred 10 years’ related experience may be considered in lieu of degree 6-8 years audit, supply chain management, manufacturing/corporate accounting, compliance, or legal related experience required 2+ years of experience as a Small Business Liaison Officer or related position either in government or industry required Previous experience with cost management and supervision Familiarity and experience with the Uniform Commercial Code and Federal Government procurement laws and regulations, specifically FAR and DFARS Experience with government compliance issues required, especially with DCAA/DCMA/SUPSHIP Ability to gather, analyze and evaluate facts and to prepare concise oral and written reports Familiarity and experience with U.S. Government Small Business websites for reporting, monitoring and information gathering. Experience with internal & external audit firms preferred Microsoft Office experience is required with proficiency in Excel Ability to work with limited direction in a fast-paced environment Excellent oral and written communication skills Demonstrates ability to multitask and to work collaboratively with other functional groups Strong analytical, written/verbal communication, interpersonal, and relationship building skills Experience leading, coaching and developing staff ERP/MRP: IFS preferred; others like BAAN, SAP, JD Edwards and Oracle are acceptable DIRECTION EXERCISED: Provides direction to all employees and departments with regard to adherence to state and federal regulations. Has authority to provide work direction and establish performance standards for employees assigned. Responsibility to supply constructive feedback to employees and provides input for performance that may affect employment actions. DISCRETION EXERCISED: Ability to work independent and exercise sound judgment. Exercises a wide degree of latitude and creativity when analyzing issues and suggesting solutions. Relies on extensive experience and judgment to plan and accomplish goals. LIAISES WITH: SCM Management, Controller, CFO, DCAA/SUPSHIP, Compliance Consultants and Authorities. The candidate will collaborate across various functions in the supply chain such as Material Program Planning, Estimating, Business Development, Contracts, Programs Procurement, Manufacturing, Quality, and Logistics. ADDITIONAL GUIDELINES: The ability to obtain and maintain a DoD clearance may be required if deemed necessary in the scope of your position responsibilities. Candidates must meet the following employment eligibility guidelines to be considered for employment with Austal USA: 18 years of age or older at time of application Able to provide proof of US Person Status No felony convictions of Theft/Deception or Violent crimes within seven years from disposition date No felony convictions of Drug crimes within three years from disposition date Willing to submit to a drug screen Willing to submit to a background check Equal Employment Commitment Any qualified individual with a disability who is having difficulty in completing an application because of incompatible technology or other disability-related application issues may contact us at the following phone number for assistance: 251-445-1932. Austal shall abide by the requirements of 41 CFR §§ 60-1.4(a), 60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity, or national origin. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability. Austal’s commitment to equal employment opportunity applies at all levels of employment, in all job titles, including the executive level, and to all employment actions, including but not limited to decisions concerning recruitment, hiring, training, and promotion.

Posted 30+ days ago

Data and Compliance Specialist, Patient Advocacy-logo
Jewish Family Service of San DiegoSan Diego, California
Position Title : Data and Compliance Specialist Organization : Jewish Family Service of San Diego Department: Patient Advocacy Position Type : Full-Time (37.5+ hours/week), Non-Exempt Work Setting: Fully Onsite Reports To: Director of Patient Advocacy Pay Range: $29-$32/hour Total Compensation : In addition to standard pay, compensation for this position includes: Comprehensive, low-cost healthcare coverage for employees Generous employer 401(k) contributions Employer-covered life insurance Time Away from Work: Being able to take time away from work is critical in bringing your best self to work. Time off benefits for this position include: Paid vacation time and sick leave 15 paid holidays, including Federal and Jewish holidays (as long as the holiday lands on a normal scheduled work day), and floating holidays 2 Wellness Days to be taken any time during the year to support employees’ mental wellness Position Overview: Under the direction of the Director of Patient Advocacy, the Compliance and Data Specialist is responsible for ensuring that contract requirements are met according to the terms set forth in the statement of work. This position may also assist the Director of Patient Advocacy with other compliance, administrative, reporting, and management issues. Responsibilities : Enter data in program database and maintain records and logs of all activities in a timely manner Oversee grant/contract and other funder requirements for the Patient Advocacy Program, including subcontracts and MOUs Assist with data management, including tracking and data collection Assist with program implementation plans and program scheduling Assist program management staff with creation and submission of contract required quarterly and annual reports Monitor program to ensure that each project or deliverable is completed on time, on budget, and in compliance with the funders’ requirements Provide progress reports and county requested reports as directed Assist Director of Patient Advocacy with budget development and oversight Work with program staff and JFS Accounting Department, as directed, relative to outcome measures, fiscal oversight, and administrative requirements Work with JFS Grants Department in development of proposals Skills/Experience/Abilities That Are a Must-Have: Bachelor’s Degree required General knowledge of accounting principles, grants, and contracts Good problem-solving abilities Strong sense of ethics and organizational skills Excellent oral and written communication skills Ability and willingness to learn and utilize new computer applications and office equipment such as computers, fax machines, telephones, and cell phones Ability to work independently and as part of a team Must have proficiency in Microsoft Word, Excel, JotForm, Microsoft Form, and other software applications Must be flexible, display a positive work attitude, and adhere to agency policies and procedures Skills/Abilities We’d Like You to Have : Bilingual is a plus Master’s degree preferred Important Notice: Please submit your resume and cover letter on your application. Incomplete submissions will not be considered. Please, no phone calls. Please, principals only. Please, local candidates only (relocation is not provided). About Jewish Family Service of San Diego Jewish Family Service of San Diego is a client-centered, impact-driven organization working to build a stronger, more resilient community. For over 100 years, Jewish Family Service has been a trusted resource for the entire community, offering an array of services that are always life-changing, and often life-saving. At Jewish Family Service, we believe our employees are the backbone of our Agency. We strive to ensure that each employee is treated with dignity and respect. Our goal is your success. Come work at JFS and be our partner in Moving Forward Together . To learn more about JFS, please visit jfssd.org. *Jewish Family Service is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Posted 3 weeks ago

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MS Services GroupBaltimore, Maryland
Morgan Stanley is a leading global financial services firm providing a wide range of investment banking, securities, investment management and wealth management services. The Firm's employees serve clients worldwide including corporations, governments and individuals from more than 1,200 offices in 43 countries. As a market leader, the talent and passion of our people is critical to our success. Together, we share a common set of values rooted in integrity, excellence and strong team ethic. Morgan Stanley can provide a superior foundation for building a professional career, a place for people to learn, to achieve and grow. A philosophy that balances personal lifestyles, perspectives and needs is an important part of our culture. The Bank Compliance Department is charged with oversight and coordination of the Compliance program for the U.S. Banks (Morgan Stanley Bank, N.A. and Morgan Stanley Private Bank, National Association). The candidate will join the Bank Institutional Compliance team as an Institutional Banking Compliance Generalist. Bank Institutional Compliance provides coverage compliance for institutional business activities executed on Morgan Stanley Bank, N.A. including capital markets, lending, and swap dealer activities. The individual will provide compliance coverage and support for the Bank Institutional Compliance team, including coverage of related business areas. This role will play a key part in assisting with the execution of compliance-related processes by contributing to strategic initiatives and supporting the development and enhancement of MSBNA's compliance framework. The role offers the opportunity to develop subject matter expertise across a wide range of regulatory topics and grow into a critical member of the team supporting the Bank's compliance program and institutional business functions. Primary Responsibilities > Support compliance coverage for the institutional banking businesses, including coordination with other compliance teams and control partners. > Conduct and support compliance risk assessments and deep-dive reviews of business practices > Develop, review, and enhance policies, procedures, controls, and training to address regulatory requirements and business changes > Coordinate and support reviews of new business initiatives, products, risk assessments, controls, and services, including the NPA process, trader mandates, surveillance and related controls, quarterly business reviews and regulatory inquiries > Prepare compliance related KRIs and dashboards > Collaborate with global and regional colleagues to ensure consistent application of compliance standards. Skills Required: > Bachelor's Degree > 2-5 years of compliance, regulatory, or related experience, with knowledge of the financial service industry, regulatory requirements, and experience in analyzing business risk and best practices > Familiarity with institutional trading and lending products > Knowledge of bank laws and regulations, particularly from the OCC, Federal Reserve, CFPB and FDIC > Organizational skills to manage multiple projects and ability to work independently > Strong relationship-building skills and ability to partner with clients to develop practical solutions that meet business needs while remaining compliant with applicable laws and regulations Skills Desired: > Strong analytical and problem-solving abilities, including the ability to explain/support conclusions from analysis > Understanding of trading workflows, front-office systems, and product structures across multiple asset classes > Interest in learning and developing broad-based compliance knowledge and growing within a dynamic team > Ability to build & maintain credible relationships > Ability to identify and escalate issues effectively and appropriately WHAT YOU CAN EXPECT FROM MORGAN STANLEY: We are committed to maintaining the first-class service and high standard of excellence that have defined Morgan Stanley for over 89 years. Our values - putting clients first, doing the right thing, leading with exceptional ideas, committing to diversity and inclusion, and giving back - aren’t just beliefs, they guide the decisions we make every day to do what's best for our clients, communities and more than 80,000 employees in 1,200 offices across 42 countries. At Morgan Stanley, you’ll find an opportunity to work alongside the best and the brightest, in an environment where you are supported and empowered. Our teams are relentless collaborators and creative thinkers, fueled by their diverse backgrounds and experiences. We are proud to support our employees and their families at every point along their work-life journey, offering some of the most attractive and comprehensive employee benefits and perks in the industry. There’s also ample opportunity to move about the business for those who show passion and grit in their work. To learn more about our offices across the globe, please copy and paste https://www.morganstanley.com/about-us/global-offices​ into your browser. Salary range for the position: $83,000 - $115,000/Yr. The successful candidate may be eligible for an annual discretionary incentive compensation award. The successful candidate may be eligible to participate in the relevant business unit’s incentive compensation plan, which also may include a discretionary bonus component. Morgan Stanley offers a full spectrum of benefits, including Medical, Prescription Drug, Dental, Vision, Health Savings Account, Dependent Day Care Savings Account, Life Insurance, Disability and Other Insurance Plans, Paid Time Off (including Sick Leave consistent with state and local law, Parental Leave and 20 Vacation Days annually), 10 Paid Holidays, 401(k), and Short/Long Term Disability, in addition to other special perks reserved for our employees. Please visit mybenefits.morganstanley.com to learn more about our benefit offerings. Morgan Stanley's goal is to build and maintain a workforce that is diverse in experience and background but uniform in reflecting our standards of integrity and excellence. Consequently, our recruiting efforts reflect our desire to attract and retain the best and brightest from all talent pools. We want to be the first choice for prospective employees. It is the policy of the Firm to ensure equal employment opportunity without discrimination or harassment on the basis of race, color, religion, creed, age, sex, sex stereotype, gender, gender identity or expression, transgender, sexual orientation, national origin, citizenship, disability, marital and civil partnership/union status, pregnancy, veteran or military service status, genetic information, or any other characteristic protected by law. Morgan Stanley is an equal opportunity employer committed to diversifying its workforce (M/F/Disability/Vet).

Posted 1 week ago

Senior Associate - Quality Control & Compliance Manager-logo
Rowan Digital InfrastructureDenver, Colorado
Rowan Digital Infrastructure is redefining how data centers are delivered—faster, smarter, and at scale. We partner with hyperscale customers to provide tailored, high-performance infrastructure with a focus on sustainability, efficiency, and flexibility. Our experienced, end-to-end team delivers custom solutions across a growing portfolio of strategic sites in key markets across the United States. Backed by Quinbrook Infrastructure Partners, Rowan is committed to enabling the next generation of digital infrastructure—and building a more sustainable future in the process. Ready to help transform how the world’s most important technologies are powered? Join us. Role Summary Rowan Digital Infrastructure is looking for a Senior Associate, Quality Control & Compliance Manager to ensure the overall effectiveness of our Quality Program and lease compliance for a set of projects. The successful candidate will have the experience, knowledge and leadership skills to manage the quality program and activities at a hyperscale data center campus to contribute to a safe and successful delivery, with quality, on time and on budget. The successful candidate will also understand all facets of the building process, from initial planning and foundational work to project completion and turnover. Travel: Ability to travel up to 40% for company gatherings or to project sites. Location: Denver, CO (hybrid in-office role) Compensation: $110-$135K - Offers Bonus Essential Responsibilities Responsible for actively monitoring the quality control program from an owner/developer perspective on all site infrastructure, substation and construction Ability to plan and lead quality discussions as needed Work closely with Rowan pre-con, project executive, PM’s, construction, and safety team members Develop trusting relationships with clients, JHA’s, GC’s, sub-contractors to aid in the successful delivery of the project Conduct site surveys to ensure work is installed per contract documents and work with PMs to update schedule with quality control inspection activities Lead closeout efforts as we approach substantial completion to assemble all closeout documents, O&M manuals and warranty, preventive maintenance agreements, -etc. Provide continuous improvement to the Rowan and our partner QA/QC programs Duties to include but not limited to: Actively work in Procore as your primary documentation tool Read and review client-specific requirements and check for compliance Lead Weekly PM Lease Compliance Meetings Participate in weekly GC’s Quality Control meetings and provide input on schedule items as required Review General Contractor’s approve QC Plan Management of compliance of the GC’s QC Plan and other Div 1 compliance plans Track schedule deliverables to ensure the project stays on track with submittals and procurement Update tracking logs for GC deliverables and milestones tracking Review Submittals schedule from GC for completeness Review both GC and Rowan monthly reports for accuracy Observe/Witness Quality Inspections, Tests, and Recording Findings Coordinate Rowan 3rd Party Inspections Document any Deficiencies Lead Project Quality Audits Ensure Materials being installed match Approved Submittals Ensure asset tracking tags are applied to equipment when it arrives Ensure the GC is performing any Preventative Maintenance (PM) on equipment as required Observe that the GCs QM is accurately assessing subcontractor quality and performing 3-Phases of Control for each DFOW; and attend all preparatory meetings Observe that quality standards are achieved before approving the subcontractor or work crew's completion of work Ensure GC is meeting or exceeding all applicable codes, industry standards, and manufacturer specifications as well as meeting or exceeding our customers’ contract and individual requirements Track the number of rework items identified throughout the project and other project-specific metrics for each project Document quality control activities including photos Review and record transmission of items to the client Waste Management and sustainability tracking Participate in design review meetings and quality reviews of drawings for compliance as required Education, Skills, and Experience Relevant college degree or commensurate relevant experience Relevant construction experience (3 years minimum) for a decently sized general contractor or owner developer Previously held site-based QA/QC roles for a minimum of 2 years OSHA training is a plus Background in Data Center development Be familiar with large projects or have a history of multiple projects running at the same time Knowledge of construction worksite safety practices Proficient in Procore and other construction management software Working knowledge of green building practices Excellent communication and collaboration skills Strong organizational skills Strong analytical and problem-solving skills Ability to work effectively in a fast-paced and highly cross-functional environment Fueled by Excellence & Collaboration At Rowan, we are a distributed team united by a common mission to transform data center delivery. Across our two offices, we offer a hybrid work environment supported by the teamwork, technology, and in-office gathering time to help you be successful. We are headquartered in Denver, Colorado and have an office in Seattle, Washington. Our team of talented and passionate individuals is spread out across the U.S. Here to support you At Rowan, we want to make sure you can do great work. We offer competitive benefits focused on helping you be and achieve your best. Hybrid working environment Team building and educational opportunities Generous benefits package including robust health benefits and a 401(k) company contribution Unlimited PTO Competitive compensation and bonus plan Equal Opportunity Employer Rowan Digital is an equal-opportunity employer. We welcome and celebrate diversity in all aspects of our workforce. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other legally protected status. We strive to create an inclusive environment where everyone can thrive.

Posted 3 weeks ago

Pfizer logo

Senior Compliance Specialist

PfizerSanford, North Carolina

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Job Description

Use Your Power for Purpose

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve 

This position reports to the Manger of Operations Compliance at the Sanford site. The position is responsible for maintaining compliance, inspection readiness, cGMP auditing, manufacturing CAPAs, manufacturing change controls, commitments (PQS, audit response, and CAS reports), manufacturing risk assessment facilitation, and interactions with internal and external Regulatory agencies (FDA, EMEA, etc.)  Key focus is the oversight quality related requirements for operations areas and executing tasks to ensure full cGMP compliance.

The Senior Compliance Specialist is accountable for supporting manufacturing functions to optimize compliance and productivity across Sanford Operations.  Working in strong partnership with Engineering, Maintenance & Utilities (EMU), Technical Services, Quality, EHS, and Operational Excellence.  This SME will provide core support to the overall compliance and success of the 24/7 operations team. Will accompany internal and external Regulatory auditors and interact with agencies during cGMP inspections.  Will provide and assist in audit responses. 

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Change control ownership for operations

  • Manufacturing ownership for CAPAs

  • Manufacturing risk assessment facilitation

  • System administrator for data integrity reviews and account recertifications

  • Audit readiness and responses

  • Manufacturing point of contact for commitments

  • Ensuring compliance with Standard Operating Procedures (SOPs), current Good Manufacturing Practice regulations (cGMP), and corporate policies and safety practices

  • Focus on Safety and GMP Compliance as operational priorities and as performance measures that should be included in metrics.

  • Self-motivated and able to adapt to rapidly changing priorities.

  • Strong oral and written communication skills.

  • Participate in and may take a lead in decision making process.

  • Engage and inspire their team members on performance expectations and coach the team to meet those expectations using Coaching Skill principles.

  • Lead and support continuous improvement efforts, where applicable.

  • Be a role model to support a positive compliance culture.

  • Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data Integrity principles.

Here Is What You Need (Minimum Requirements) 

  • Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience;
    OR an associate's degree with 6 years of experience; OR a high school
    diploma (or equivalent) and 8 years of relevant experience.

  • Demonstrate experience in compliance, project management, and system administration in a multi-layered organization Experience in two of the following areas is desired: Manufacturing, Materials Management/Planning, QA, QC, Technical Services, and Engineering. 

Bonus Points If You Have (Preferred Requirements) 

  • Formal experience in the Manufacturing, Technical, or Quality organizations is highly desired.

PHYSICAL/MENTAL REQUIREMENTS

Job will require regular walks and observations within the manufacturing facilities.

Non-Standard Work Schedule, Travel or Environment Requirements 

Nonstandard work schedule may be required to support site regulatory inspections.

OTHER JOB DETAILS

Last Date to Apply for Job: August 27, 2025.

Referral Bonus Eligibility: YES

Eligible for Relocation Package: NO

The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Pfizer is an E-Verify employer.  This position requires permanent work authorization in the United States.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

Quality Assurance and Control

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