Senior Regulatory Compliance Specialist

Johnson & Johnson is currentlyrecruiting foraSenior Regulatory Compliance Specialist! This position canbe located inCornelia or Athens, Georgia.

Position Summary:

Under the supervision of the Regulatory Compliance Manager, the Senior Regulatory ComplianceSpecialistis responsible formaintaininga robust compliance program to ensure compliance withall applicable regulatory requirements, company policies and procedures, and J&J Corporaterequirements.

The Regulatory Compliance Specialist will lead andmaintainthe internal audit program to help the site sustain a state of readiness to applicable regulatory requirements. Leads and maintains assigned Compliance functions to ensure compliance to applicable regulations and directives such as 21CFR 820, 21 CFR 4, ISO 13485/EN 1SO 13485, ISO 14971/EN ISO 14971, European Medical Devices Directive, Canadian Medical Devices Regulations SOR/98-282,ANVISA RDC No. 665 (2022), Provides for Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products, Japan Ministry of Health,Laborand Welfare of Japan Ordinance No. 169, Australia Therapeutic Goods (Medical Devices) Regulations, and any other regulations or standards applicable to the site.   Participates in site internal audits as a team or lead auditor to ensure compliance with all applicable quality system standards and directivesin accordance withinternal audit schedule. Leadsinspectionreadiness activities and actively participates in conduct of external quality system audits and inspections.  Supports preparation of external audit and inspection responses. Serves on cross site project teams consistent with company goals andobjectivesto improve overall compliance performance toestablishedmetrics and requirements.Managesassigned internal and external audit observations to ensure identified gaps are closedin a timely manner.

Conducts audits to good manufacturing practices, international organization for standardization and any other applicablestandard.

Key Responsibilities:

Coaches more junior colleagues in techniques, processes, and responsibilities.​

Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

Summary of Technical Duties:

• Review of manufacturing processes,instrumentand equipmentqualifications, (IQ/OQ/PQ), design historyfile, engineering documentation, etc.

• Responsible for the data analysis and reporting for the sites andidentifycompliance issues 

• Lead,participateand/or support as needed in projects associated with audit process and application for the sites. 

• Lead/participateand/or support as needed in root cause investigations and quality systems and compliance improvements that results from Internal/External Audits, managementreviewsand any other NC/CAPA system indicators

• Process Excellence projects such as Lean Six Sigma of both new and existing processes, including but not limited to, quality improvements, cost reductions and productivity improvements.

• Complete statistical analysis of data for decision making.

Externalinspectionreadiness and associated activities. Support site audit readiness activities to ensureinspectionreadiness at alltime.

• Supports external audits and mock inspections:e.g.Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for site.  

• Executes site inspection readiness actions/tools

• Participates in audit preparation activities (auditorlogistics, front room/back roomarrangements, identifying/preparing SME’s, etc.). 

• Assesses the risk and applicability of audit observations from other J&J facilities todetermineimpacttothe site.

• Providestimelyinformation to support the inspection process.

Internal Audit Program and Management Execution

• Executes internal audits, as a team or lead auditor, against established internal audit procedures, which can include but is not limited to audits of manufacturing processes, process/software validations, design controls, etc.

• Ensures adequate corrective actions for internal audits, including robust root cause investigations and corrective action plans, drive on-time completion of observation action plans, perform follow-up with observation owners, and perform effectiveness monitoring and closure.

• Drives compliance and improvement in audit metrics.

Enterprise / Sector Support

• Connects and collaborates with other region’s compliance teams.  

• Conductsaudits at other sites as needed.

• Execute and/or supports Process Excellence projects as well as Lean Six Sigma of both new and existing processes, including but not limited to, quality improvements, cost reductions and productivity improvements.

Metrics Collection and Reporting

• Trend, analyze,createsreports andcommunicatesperformance against metrics to key stakeholders. 

• Highlights/communicates adverse trends in metrics, and takerisk basedaction to remediate.  

Escalations

• Escalates itemsin accordance withestablished procedures.

External Standards and Regulations

• Supports implementation of new external standards/regulations for the site.

• Maintains current knowledge of regulatory changes through industry publications, seminars, professionalaffiliationsand industry meetings.

Site Management Review and Quality Reviews

• Provides input (e.g.,internaland external audit results/status) into Site Management Reviews, Corrective Action ReviewBoardsand Plant Quality Reviews to allow meaningful review.

• Participates in reviews as.

Other tasks

• Establishes strong connection and collaboration with business partners at thesite, (e.g.Quality Operations, Training, Engineering and Manufacturing).

• Whereappropriate,participateon required site teams/projects

• Plan, conduct and direct compliance projects requiring advanced knowledge of a

specialized field.

• Apply comprehensive and diverse knowledge of quality systems within broad assignmentareas.

• May coordinate and direct activities of wageemployees;responsible for their developmentplans.

• Interact with other sites to exchange support and resources aimedto attaincommoncomplianceobjectives.

• Make decisions and propose solutions to quality issues which couldprecludea timelyoreffectivenessimplementation of compliance programs and initiatives.

• Support executionand management of activities related to external audit readiness, data trending, and theinternal audit program.

• Provides compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational strategies.

• Supports and promotes the safety and environmentalobjectivesof the facility.Comply withall environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001).

Qualifications:

Education:

A minimum of aBachelorsor equivalent University degree is, with a focus in Engineering or Technical field preferred.

Required:

• A minimum of 4 - 6 years of experience inaFDA regulated industry (pharmaceutical or medical devices) or another highly regulated industry is.

• Knowledge of 21CFR 820, 21 CFR 4, ISO 13485/EN 1SO 13485, ISO 14971/EN ISO 14971, European Medical Devices Directive, Canadian Medical Devices Regulations SOR/98-282,ANVISA RDC No. 665 (2022), Provides for Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products, Japan Ministry of Health,Labourand Welfare of Japan Ordinance No. 169, Australia Therapeutic Goods (Medical Devices) Regulations.  

• Knowledge of Good Manufacturing Practices (GMPs) and Quality System Regulations (QSRs).  

• Position requires proven leadership skills in associate involvement and teamwork, initiative, creativity, assertiveness, attention to detail, and excellent interpersonal skills.

• Ability to work underpressureachieving consistently high results in quality, efficiency, and compliance through individual and team efforts.

• Ability to analyze complex data and integrate multi-disciplinary feedback.

• Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required. Experience with Microsoft Project.  

• Excellent communication and interpersonalrelationskills.

Preferred:

• Experience in Quality,Manufacturingor Engineering roles. 

• Experience leading internal quality system audits is preferred (Engineer and Senior Engineer level) and(Staff Engineer level).  

• Experience leading or managing an internal audit program. 

• Training in Process Excellence/Six Sigma tools and methodologies and Certification.  

• Current Certified Quality Audit (CQA), Certified Biomedical Auditor (CBA)and/or Lead Auditor certification.  

• Experience in leading and managing projects and milestones.  

• Experience with Minitab. 

• Advanced computer and database management skills.

• Statistical and analytical problem solving.

Other:

• This position may require up to 15% domestic & international travel

• This role is eligible for relocation funding

Johnson & Johnsonisan Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal,stateor local law. We actively seek qualified candidates who areprotectedveterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.Johnson & Johnsoniscommitted to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request anaccommodation,  externalapplicants please contact us viahttps://www.jnj.com/contact-us/careers .internalemployees contactAskGSto be directed to your accommodation resource.