Group Manager - Quality Control

Pfizer; India; On-site; INR 3,500,000 - 5,200,000; Full time

Job summary

Pfizer India invites an experienced Quality Control leader to drive excellence across QC operations, stability management, and regulatory compliance. You will lead multi-disciplinary teams, oversee analytical testing, and ensure data integrity and lifecycle management of QC instruments.

The role emphasizes collaboration with Manufacturing, QA, Engineering, R&D, and Supply Chain to meet site goals and uphold Pfizer quality standards. A strong background in cGMP and people leadership is essential.

Qualifications

• Experience in pharmaceutical QC with cGMP compliance.
• Proven leadership and people-management capabilities.
• Strong understanding of QC instrumentation and analytical methods.

Responsibilities

• Lead, coach, and manage Quality Control teams through goal setting, performance reviews, feedback, development planning, and succession readiness.
• Plan, manage, and oversee analytical activities related to in‑process, finished product, stability, process validation, exhibit batch, market complaint, and retention sample testing.
• Ensure equipment qualification and lifecycle compliance for QC laboratory instruments.
• Approve and manage stability and retention sample requests, protocols, and annual submissions.
• Ensure alignment with cGMP, regulatory requirements, and Pfizer Quality Standards across all QC activities.
• Guide analysts in continuous improvement tools, digitization, and LEAN/Six Sigma initiatives.
• Collaborate with Manufacturing, QA, Engineering, R&D, and Supply Chain to support site objectives.

Skills

Leadership & People Management

Quality Control & Lab Operations

Equipment Qualification

Stability Management

Compliance & Audits

Continuous Improvement

Collaboration & Partnership

Education

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

Job description

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
  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:
  1. Analytical testing, stability management, and retention samples
  2. Equipment qualification, calibration, and maintenance oversight
  3. Audit handling and regulatory inspections
  4. Incident, CAPA, Change Control management
  5. People leadership and performance management
  6. Proficiency in a wide range of analytical techniques and QC instrumentation.

Bonus Points