Group Manager - Quality Control

Pfizer; India; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Pfizer is seeking a seasoned Quality Control leader for its on-site India operations. The role focuses on guiding QC teams, ensuring cGMP compliance, and driving continuous improvement in analytical testing, stability management, and data integrity across multiple QC activities.

Key responsibilities include oversight of QA/QC workflow, collaboration with Manufacturing, R&D, and Supply Chain, and leading audits and investigations to maintain regulatory readiness and product quality.

Qualifications

• A strong background in Quality Control in the pharmaceutical industry.
• Extensive knowledge of cGMP compliance for QC laboratories.
• Experience in analytical testing, stability management and lab investigations.

Responsibilities

• Lead, coach, and manage Quality Control teams with performance reviews and development planning.
• Plan, manage, and oversee analytical activities including in-process, finished product, stability and related testing.
• Ensure equipment qualification, calibration, maintenance, and lifecycle management for QC instruments.
• Represent CQ during internal and external audits and inspections; support investigations and CAPA closures.

Skills

Leadership

People Management

Quality Control

Laboratory Operations

Audits & Compliance

Continuous Improvement

Risk-based Decision Making

Cross-functional Collaboration

Data Integrity

Education

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

Job description

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.
• 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

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