Group Manager - Quality Control

Role overview

Group Manager - Quality Control at Pfizer

In this role, you will:

Responsibilities

• Lead, coach, and manage Quality Control teams through goal setting, performance reviews, feedback, development planning, and succession readiness.
• 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.
• Ensure equipment qualification and lifecycle compliance for QC laboratory instruments, including IQ/OQ/PQ activities.
• Ensure Equipment Qualification protocols, reports, deviations, and change controls are reviewed and approved.
• Collaborate with Engineering, Validation, and QA to support:
• Ensure data integrity, ALCOA+ principles, and computerized system compliance for analytical instrumentation.
• 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.
• Ensure personnel safety, safe material handling, and adherence to EHS requirements within QC laboratories.
• 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.

Required qualifications

• B.
• Pharm / M.
• Pharm / M.Sc.
• 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.
• 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

Preferred qualifications and skills

• Bonus Points If You Have (Preferred Requirements)

Employment details

• Location: India - Vizag

Application details

• Guide analysts in the application of continuous improvement tools such as standard work, visual management, LEAN, and Six Sigma methodologies.

About the employer

• Ensure alignment with cGMP, regulatory requirements, and Pfizer Quality Standards across all QC activities.

Additional role details

• 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
• Leadership & People Management
• 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
• Equipment Qualification, Calibration & Lifecycle Management
• Oversee calibration, preventive maintenance, and requalification of QC equipment in accordance with approved schedules and regulatory requirements.
• New equipment introduction
• Decommissioning and replacement activities
• Qualification impact assessments for changes
• Stability Management
• Approve and manage stability and retention sample requests, protocols, reports, and annual submissions.
• Compliance, Audits & Quality Systems
• 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.
• Continuous Improvement & Technical Excellence
• Drive simplification, digitization, and efficiency improvement initiatives across CQ processes.
• 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)