Sr Manager, Computer System & Software Medical Device Quality
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Job Description
Use Your Power for Purpose
This position is a member of the Software Medical Device (SMD) Quality Assurance team within the Pfizer Global Supply (PGS) organization and provides end-to-end quality assurance support to SMD Legal Manufacturer and Product teams for the development, testing, deployment, maintenance and decommissioning support of SMDs.
What You Will Achieve
The incumbent provides quality assurance guidance of SMDs to the organization related to design controls (21 CFR 820), Quality Management Systems (ISO 13485), risk management (ISO 14971), clinical trials, vendors, complaints, post-market surveillance, regulated body inspections, applicable internal procedures, and other applicable regulatory requirements (EU Medical Device Regulations) throughout the product lifecycle.
Additionally, the position supports Computer System Validation & Quality oversight for GMP /GDP Digital systems as necessary, ensuring compliance with 21 CFR Part 11, Eudralex Vol 4 Annex 11 & associated global regulations.
In this role, you will:
Duties can be adjusted based on the group’s requirements and needs.
Duties may include but not limited to the following:
- Provide Quality Assurance oversight for Software Medical Devices (SMD) designed and developed by Pfizer Digital and third parties, and commercial SMDs.
- Provide Quality Assurance oversight for the Software Medical Device Quality Management System (QMS) and the SMD Legal Manufacturer (SMDLM).
- Support quality governance through the support & chairing of Management Review/SMD S-QRT, and support of OpU-QRT forums.
- Ensuring & monitoring Vendor quality management systems and their performance
- Support Internal, BOH (Board of Health) inspections, ISO certifications, and vendor audits.
- Provide Quality Assurance leadership and direction to SMD/CSV projects.
- Ensure device design and development, and product development meets appropriate regulatory requirements by providing pro-active guidance through all stages of development.
- Partner with project teams, as required, in the resolution of investigations, deviations and change control.
- Determine the impact of these events and escalate in accordance with Pfizer processes.
- Perform, Review and Approve investigations.
- Author & approve SOPs.
- Review and approve Solution Delivery Lifecycle (SDLC) deliverables for as Business Unit Quality Assurance (BUQA).
- Perform QA commercial release of all Pfizer SMDs.
- Perform QA production release for enterprise GMP/GDP systems.
- Investigate complaints and support post market surveillance for commercial products.
- Lead Continuous Improvement projects to optimize quality processes and systems to support effective and compliant delivery of the product portfolio.
- Provide device design and development quality expertise to Pfizer Global Supply (PGS) sites and contractors as required.
- Provide device expertise to PGS audits of external contractors involved in the aspect of device development and manufacture.
- Provide medical device, CSV and quality mentorship and advice.
- Provide quality expertise to PGS for development/enhancement/deployment of GSOPs
- Support product recalls & market actions as necessary.
- Support product complaints and post market surveillance for commercial products.
- Role may include business travel to other Pfizer sites, contractors, and suppliers.
Here Is What You Need (Minimum Requirements)
- Bachelor’s degree with at least 6+ years of experience; OR a Master’s degree with more than 5+ years of experience; OR a Ph.D. with 1+ years of experience.
- Good understanding of Quality Management System regulations
- Experience of SMD development and/or Software Quality Assurance, including risk based approaches (e.g., CSA, GAMP5, QRM)
- Experience of enterprise system validation/compliance/ deployment and intimate knowledge of Pfizer Digital life cycle methodologies (S/ADLC)
- Experience in a GMP regulated environment in SMD, Medical Device development, Computer System and/or automation Validation.
- Experience working in the Pharmaceutical/Medical Device Industry.
- Demonstrated experience with SMD Quality management and/or computer system validation lifecycle processes
- Intimate knowledge of SMD, Medical Device & Computer System Quality regulations
- Excellent communication skills with the ability to build relationships, influence outcomes, and to deliver effective viewpoints or presentations to a variety of audiences.
- Command of the English language
- Be self-motivated and flexible with the ability to work effectively in a dynamic, problem solving environment.
- Ability to work within tight timeframes and respond to changing requirements.
- Ability to interact comfortably with all levels of management and colleagues.
- Ability to work independently and manage multiple projects simultaneously.
- Competency in MS Office and other tools (e.g. MS Project).
- Basic understanding of data analytics, statistics and Artificial Intelligence.
Bonus Points If You Have (Preferred Requirements)
- Involvement in industry discussion forums on SMD/CSV-related topics.
- Experience of interacting with auditors and inspectors.
- Experience of computer system/business process ownership.
- Experience of software development, design controls, risk management and delivery.
- Experience of Data science/engineering.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Standard M-F work week
None/little travel
Occasional off-shift requirements
Work Location Assignment: Hybrid
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.
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.