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The Role
Provide QA oversight for GMP investigations (manufacturing and lab), manage investigation-related quality systems (Nonconformance, CAPA), review/approve investigation records, support inspection readiness, drive quality system improvements, act as DPOC/super-user for TrackWise and Vault QMS, mentor junior QA staff, and apply QRM and continuous improvement to maintain product quality and compliance.
Summary Generated by Built In
Why Patients Need You
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.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
Position Summary
The incumbent is a member of the Quality Assurance (QA) Operations team. Under the supervision of the Senior QA Manager, the incumbent will be responsible for the following:
How You Will Achieve It
Job Related Requirements
Qualifications and Experience
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control
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.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
Position Summary
The incumbent is a member of the Quality Assurance (QA) Operations team. Under the supervision of the Senior QA Manager, the incumbent will be responsible for the following:
- Provide Quality Assurance (QA) oversight of Good Manufacturing Practice (GMP) investigations, including manufacturing and laboratory investigations, to ensure products comply with Pfizer Quality Standards (PQS) and International Council for Harmonisation (ICH) guidelines.
- Serve as the local process owner for investigation-related quality systems, including Nonconformance, Corrective and Preventive Actions (CAPA), and Management / Board of Health Notifications.
- Maintain awareness of regulatory expectations and support site inspection readiness.
- Promote a strong quality culture and GMP-compliant behaviours at the site.
- Drive quality system improvements in collaboration with cross-functional teams.
- Contribute to the site vision of being a best-in-class manufacturing site that produces high-quality products safely.
- Apply the IMEx way of working to day-to-day operations, problem solving, escalation, and continuous improvement.
- Mentor QA team members, including training QA approvers for investigations.
How You Will Achieve It
- Provide QA oversight of GMP investigations, including manufacturing and laboratory investigations; issue Management Notifications; and implement batch controls related to investigations, such as batch holds and quarantine notifications.
- Review and approve GMP records associated with investigations, including investigation reports, manufacturing records related to investigation actions, CAPA, and effectiveness checks, in accordance with site procedures. Ensure that root cause analyses, corrective and preventive actions, and quality, validation, stability, and regulatory impact assessments are adequate. Escalate issues as required.
- Serve as the local process owner for investigation-related quality systems, including site representation at global Process Centric Teams (PCTs) and authoring related site procedures and documentation.
- Serve as site trainer for investigation-related roles and system access, such as QA approver for investigations.
- Perform Designated Point of Contact (DPOC) and super-user responsibilities for assigned site platforms supporting quality systems, such as TrackWise and Vault QMS, as nominated.
- Prepare periodic review reports, analyze trends, recommend improvement actions, and monitor relevant metrics to ensure investigation-related quality systems remain in a state of control.
- Conduct or support market actions related to investigations, including mock recalls, as required by procedures.
- Apply quality risk management (QRM) principles to support risk assessments and mitigation actions.
- Maintain inspection readiness and support inspections by internal auditors, regulatory agencies, and customers. Participate in GMP walkdowns to verify that site operations and facilities remain inspection-ready and comply with site procedures and PQS.
- Support maintenance of the validated state of GMP systems and processes.
- Uphold Pfizer's Code of Conduct and values and demonstrate Pfizer's actionable attributes.
- Actively participate in Tier processes by updating performance against metrics, highlighting and resolving issues, escalating appropriately, and implementing solutions.
- Mentor junior QA team members, including interns.
- Participate in safety initiatives and perform Environmental, Health and Safety (EHS)-related investigations, as needed.
Job Related Requirements
- Ability to act decisively and independently to resolve issues, with appropriate escalation as required.
- Ability to work effectively in a team and mentor junior team members.
- Demonstrates a proactive mindset and commitment to delivering high-quality outcomes.
- Adopts digital technology to improve the speed, scale, and effectiveness of interactions and actions.
Qualifications and Experience
- Degree in Chemistry, Microbiology, Engineering or other Science related discipline.
- Minimum of 4 years of experience, including QA experience, within the pharmaceutical industry.
- Compliance, regulatory, or validation experience is an advantage.
- Strong written and verbal communication skills; technical report writing experience is an advantage.
- Demonstrated personal leadership, accountability, and organizational skills, with proven ability to operate independently with minimal supervision. Experience working in a cross-functional, matrix environment is an advantage.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control
Skills Required
- Degree in Chemistry, Microbiology, Engineering or other science-related discipline
- Minimum of 4 years experience including QA experience in the pharmaceutical industry
- Knowledge of GMP, Pfizer Quality Standards (PQS), and ICH guidelines
- Experience performing and overseeing GMP investigations, root cause analysis, and CAPA management
- Experience with TrackWise and Vault QMS as DPOC/super-user
- Ability to act decisively and independently, escalate appropriately
- Ability to work effectively in cross-functional teams and mentor junior staff
- Strong written and verbal communication skills
- Technical report writing experience
- Compliance, regulatory, or validation experience
- Experience working in a cross-functional, matrix environment
- Adopts digital technology to improve processes and interactions
What the Team is Saying
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Pfizer Compensation & Benefits Highlights
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Healthcare Strength — Official materials describe comprehensive medical, dental, vision, and mental-health support, plus fertility/family‑building and transgender‑inclusive coverage; eligible Pfizer medications are noted as available at no cost in U.S. plans. Wellness resources such as telehealth and preventative programs are also emphasized.
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Retirement Support — Company documents highlight a 401(k) with matching contributions plus an additional Retirement Savings Contribution beyond the match. Financial planning support and company‑paid life and disability insurance further bolster long‑term security.
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Leave & Time Off Breadth — Corporate pages and job postings describe paid vacation and holidays, caregiver leave, and paid parental leave for both parents. Materials also note that details can vary by role and location.
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The Company
What We Do
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Why Work With Us
We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.
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Pfizer Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Typical time on-site:
2.5 days a week
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Rochester, MI
San Diego, CA
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