Use Your Power for Purpose
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is flexible, innovative, and customer-oriented. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work.
What You Will Achieve
In this role, you will:
- Leadership & People Management
- Lead, coach, and manage Quality Control teams through goal setting, performance reviews, feedback, development planning, and succession readiness.
- Identify development needs, foster teamwork, inclusion, and a culture of accountability and continuous improvement.
- Manage workforce planning, leave management, and performance appraisal cycles.
- Actively share knowledge, encourage innovation, and support risk‑based decision making.
- Quality Control & Laboratory Operations
- Plan, manage, and oversee analytical activities related to:
- In‑process, finished product, stability, process validation, exhibit batch, market complaint, and retention sample testing
- Stability sample pulling, testing, protocol approval, compilation reports, and annual stability report submissions
- Visual inspection of retention samples per approved schedules
- Ensure timely review, approval, and completion of all QC activities in alignment with site KPIs.
- Review and approve, Laboratory investigations, QC documentation including raw data, protocols, reports, and SOPs in compliance with cGMP.
- Equipment Qualification, Calibration & Lifecycle Management
- Ensure equipment qualification and lifecycle compliance for QC laboratory instruments, including IQ/OQ/PQ activities.
- Oversee calibration, preventive maintenance, and requalification of QC equipment in accordance with approved schedules and regulatory requirements.
- Ensure Equipment Qualification protocols, reports, deviations, and change controls are reviewed and approved.
- Collaborate with Engineering, Validation, and QA to support:
- New equipment introduction
- Decommissioning and replacement activities
- Qualification impact assessments for changes
- Ensure data integrity, ALCOA+ principles, and computerized system compliance for analytical instrumentation.
- Stability Management
- Approve and manage stability and retention sample requests, protocols, reports, and annual submissions.
- Ensure sponsor‑site stability samples, review of shipment temperature excursions, and execution of stability studies at site.
- Ensure PRQ and qualification of stability chambers as per approved schedules.
- Compliance, Audits & Quality Systems
- Ensure alignment with cGMP, regulatory requirements, and Pfizer Quality Standards across all QC activities.
- Represent CQ during internal, external, customer, and regulatory audits and inspections.
- Support timely investigation and closure of Incidents, Deviations, CAPAs, and Change Controls, including cross‑functional impact assessments.
- Ensure personnel safety, safe material handling, and adherence to EHS requirements within QC laboratories.
- Continuous Improvement & Technical Excellence
- Guide analysts in the application of continuous improvement tools such as standard work, visual management, LEAN, and Six Sigma methodologies.
- Drive simplification, digitization, and efficiency improvement initiatives across CQ processes.
- Provide technical expertise in troubleshooting analytical methods, instruments, and laboratory issues.
- Support method transfers from R&D to QC and ensure readiness for routine testing.
- Collaboration & Business Partnership
- Partner with Manufacturing, QA, Engineering, R&D, Supply Chain, and external customers to support site objectives and timelines.
- Establish and monitor departmental performance metrics to drive operational effectiveness.
- Communicate complex technical concepts clearly, solicit feedback, and influence stakeholders using sound scientific and business rationale.
Here Is What You Need (Minimum Requirements)
- Education: B. Pharm / M. Pharm / M.Sc.
- Experience: Minimum 10+ years of pharmaceutical industry experience with a strong background in Quality Control.
- Extensive knowledge of cGMP compliance for Quality Control laboratories, including, testing, stability management, lab investigations, equipment qualification, and data integrity.
- Demonstrated experience in:
- Analytical testing, stability management, and retention samples
- Equipment qualification, calibration, and maintenance oversight
- Audit handling and regulatory inspections
- Incident, CAPA, Change Control management
- People leadership and performance management
- Proficiency in a wide range of analytical techniques and QC instrumentation.
Bonus Points If You Have (Preferred Requirements)
- Master's degree
- Knowledge in the application of statistical tools, root cause analysis, and/or six sigma methodologies
- Experience with environmental testing, utility monitoring, analytical testing, microbial identification, and sterility testing
- Expertise in QC instrumentation, qualification, and troubleshooting
- Experience in setting requirements for the transfer of methodology from Research and Development (R&D)
- Ability to manage projects and ongoing work activities of moderate complexity
- Excellent verbal and written communication skills
- Ability to foster teamwork and colleague development
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Work Location Assignment: On Premise
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