Be an Early Applicant
We’re in relentless pursuit of breakthroughs that change patients’ lives.
The Role
Reviews and approves pharmaceutical quality investigations, including deviations, non-conformances, OOS/OOT events, complaints, and manufacturing investigations. Evaluates root-cause analyses, data integrity, risk, CAPAs, GMP compliance, and regulatory readiness. Collaborates with cross-functional teams, coaches investigation owners, identifies recurring quality trends, supports audits and inspections, and drives timely, scientifically robust investigation closure and continuous improvement.
Summary Generated by Built In
Key Responsibilities
Key Deliverables
Education Qualification
Required Skills
Transferable Skills to Develop
Key Investigator & Reviewer Competencies
Sound judgment and decision-making abilities during complex investigations
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
- Independently review, challenge, and approve deviation, non-conformance, OOS/OOT, complaint, environmental, microbiological, and manufacturing investigations to ensure scientific robustness and regulatory compliance.
- Evaluate investigation strategies to ensure thorough fact-finding, evidence gathering, and identification of scientifically justified root causes.
- Assess data integrity, documentation accuracy, and investigation completeness to ensure conclusions are supported by objective evidence.
- Review the application of investigation tools including 5-Why Analysis, DMAIC, Fishbone Analysis, Fault Tree Analysis, Human Error Reduction tools, and Risk Assessment methodologies.
- Challenge unsupported assumptions, weak rationales, and bias to drive fact-based decision making.
- Assess product quality, patient safety, process, compliance, and business risks associated with investigation events.
- Review and approve CAPAs to ensure actions are proportionate, effective, sustainable, and aligned with identified root causes.
- Ensure compliance with site procedures, Quality Management System requirements, current GMP expectations, and global regulatory requirements.
- Drive investigation quality and on-time closure through effective collaboration with Manufacturing, Microbiology, Engineering, Validation, Quality Control, and Technical Services teams.
- Identify investigation trends, recurring events, systemic gaps, and opportunities for continuous improvement.
- Provide coaching and mentoring to investigation owners on root cause analysis, scientific rationale development, technical writing, and investigation best practices.
- Support internal audits, regulatory inspections, customer audits, and remediation activities related to investigations and CAPAs.
Key Deliverables
- High-quality investigations approved within established timelines.
- Improved effectiveness and robustness of root cause identification.
- Reduction in repeat deviations and recurring quality events.
- Enhanced CAPA effectiveness and sustainability.
- Improved compliance with GMP, data integrity, and regulatory expectations.
- Strengthened inspection readiness and reduction in investigation-related observations.
- Improved investigation closure cycle time without compromising quality.
- Development of investigation review best practices and lessons learned repository.
- Improved quality culture through effective coaching and reviewer engagement.
Education Qualification
- B.Pharm, M.Pharm, M.Sc. (Microbiology/Chemistry), Biotechnology, Pharmaceutical Sciences
- Minimum 6-10 years of experience in Quality Assurance, Quality Control, Sterile Manufacturing, or Investigation Management.
- Certification in Six Sigma, Lean, Risk Management, Human Performance, or Investigation Excellence preferred.
Required Skills
- Quality Assurance
- Quality Management Systems (QMS)
- Deviation Management
- Root Cause Analysis
- Investigation Review and Approval
- Corrective and Preventive Action (CAPA) Management
- Risk Assessment and Risk Management
- Data Integrity
- GMP Compliance
- Regulatory Compliance (USFDA, MHRA, EMA, TGA, CDSCO)
- Audit Readiness
- Technical Writing and Documentation Review
- Sterile Manufacturing Knowledge
- Quality Systems Oversight
Transferable Skills to Develop
- Critical Thinking and Scientific Reasoning
- Risk-Based Decision Making
- Investigative Interviewing Techniques
- Systems Thinking
- Problem Solving and Analytical Skills
- Data Analysis and Trending
- Stakeholder Management
- Influencing Without Authority
- Effective Communication and Coaching
- Time Management and Prioritization
Key Investigator & Reviewer Competencies
- Ability to distinguish symptoms from true root causes.
- Ability to identify investigation gaps and challenge weak justifications.
- Strong attention to detail and data review capabilities.
- Capability to evaluate investigation completeness and scientific validity.
- Strong understanding of human error, behavioral factors, and organizational contributors.
- Ability to objectively assess product quality and patient impact.
- Fact-based decision making with strong compliance orientation.
- Expertise in evaluating CAPA adequacy and effectiveness.
- Strong technical writing and report review skills.
Sound judgment and decision-making abilities during complex investigations
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
- B.Pharm, M.Pharm, M.Sc. in Microbiology or Chemistry, Biotechnology, or Pharmaceutical Sciences
- 6-10 years of experience in Quality Assurance, Quality Control, Sterile Manufacturing, or Investigation Management
- Certification in Six Sigma, Lean, Risk Management, Human Performance, or Investigation Excellence
- Experience with Quality Assurance and Quality Management Systems
- Experience with deviation management, root cause analysis, investigation review and approval, and CAPA management
- Experience with risk assessment, data integrity, GMP compliance, and regulatory compliance
- Knowledge of sterile manufacturing
- Technical writing and documentation review skills
What the Team is Saying
Daniel
Diagnostics Launch Lead
Anna
R&D Privacy Steward
Esteban
Specialist
Pfizer
Pfizer Compensation & Benefits Highlights
-
Healthcare Strength — Health coverage is described as comprehensive across medical, dental, vision, and mental‑health support, with strong plan options and provider networks. Feedback suggests these programs are a clear standout within the total rewards package.
-
Retirement Support — Retirement programs feature a 401(k) with company matching plus an additional company retirement contribution. Feedback suggests these elements are consistently highlighted as valuable components of overall compensation.
-
Leave & Time Off Breadth — Paid vacation, holidays, and sick time are often characterized as generous, with some locations offering the ability to purchase additional vacation days. Feedback suggests this breadth contributes meaningfully to work‑life balance.
Pfizer Insights
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
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.
Gallery
Pfizer Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Typical time on-site:
2.5 days a week
Hudson Yards
Provincia de Buenos Aires
Andover, MA
Athens, GR
Chennai, IN
Collegeville, PA
Durham, NC
Groton, CT
Madison, NJ
Madrid, ES
Mumbai, Maharashtra
Rochester, MI
San Diego, CA
Seattle, WA
Tampa, FL
Center for Digital Innovation
Learn more
