Pfizer

Group Manager - Quality Control

Posted 2 Days Ago

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Vizag, Vishākhapatnam, Andhra Pradesh, IND

In-Office

Expert/Leader

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

Lead and manage QC laboratory operations and teams to ensure cGMP compliance, oversee analytical testing, stability programs, equipment qualification, investigations, audits, and continuous improvement initiatives while partnering cross-functionally to meet site KPIs and regulatory expectations.

Summary Generated by Built In

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

Skills Required

Bachelor's degree in B.Pharm, M.Pharm, or M.Sc.
Minimum 10+ years pharmaceutical industry experience in Quality Control
Extensive knowledge of cGMP for QC laboratories including testing, stability management, lab investigations, equipment qualification, and data integrity
Demonstrated experience with analytical testing, stability and retention sample management
Experience overseeing equipment qualification, calibration, and maintenance (IQ/OQ/PQ)
Experience handling audits and regulatory inspections
Experience managing Incidents, CAPAs, and Change Controls
People leadership: coaching, performance management, workforce planning, succession readiness
Proficiency with a wide range of analytical techniques and QC instrumentation
Master's degree
Knowledge of statistical tools, root cause analysis, and Six Sigma methodologies
Experience with environmental testing, utility monitoring, microbial identification, and sterility testing
Expertise in QC instrumentation troubleshooting and method transfer from R&D to QC
Project management experience for moderate complexity workstreams
Excellent verbal and written communication and ability to foster teamwork
Experience using AI tools (e.g., generative technologies such as ChatGPT or Microsoft Copilot) and understanding of responsible AI practices

What the Team is Saying

Pfizer Compensation & Benefits Highlights

Healthcare Strength — Official materials describe comprehensive medical, dental, vision, and mental-health support, plus fertility/family‑building and transgender‑inclusive coverage; eligible Pfizer medications are noted as available at no cost in U.S. plans. Wellness resources such as telehealth and preventative programs are also emphasized.
Retirement Support — Company documents highlight a 401(k) with matching contributions plus an additional Retirement Savings Contribution beyond the match. Financial planning support and company‑paid life and disability insurance further bolster long‑term security.
Leave & Time Off Breadth — Corporate pages and job postings describe paid vacation and holidays, caregiver leave, and paid parental leave for both parents. Materials also note that details can vary by role and location.

Learn more about Pfizer's Compensation & Benefits →

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The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

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.