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Group Manager - Quality Control

VISAKHAPATNAM (IN)ONSITEPOSTED: 9/25/2026
PHARMAFull time
HIRING ORGANIZATIONPFIZERBiopharmaceutical / Healthcare
Pfizer

ROLE OVERVIEW

Pfizer’s Vizag site is a critical manufacturing and quality hub within its global sterile injectables and biopharmaceutical network. The Group Manager – Quality Control leads a large QC organization responsible for analytical testing, stability programs, equipment qualification, and cGMP compliance. This role directly protects Pfizer’s commercial supply, regulatory filings, and patient safety across India and export markets. It is ideal for a seasoned QC professional who wants to combine technical depth with people leadership, regulatory inspection readiness, and continuous improvement. The position offers visibility across manufacturing, QA, R&D, and global quality systems, making it a strong platform for future site quality head or global QC leadership roles. You will shape quality culture, talent development, and inspection outcomes while ensuring safe, effective medicines reach patients on time.

ROLE DEFINITION & RESPONSIBILITIES

  • •Lead, coach, and manage QC teams through goal setting, performance reviews, development planning, succession readiness, leave management, and workforce planning.
  • •Oversee analytical testing for in-process, finished product, stability, process validation, exhibit batches, market complaints, and retention samples.
  • •Review and approve laboratory investigations, raw data, protocols, reports, SOPs, deviations, CAPAs, and change controls in compliance with cGMP.
  • •Manage equipment qualification, IQ/OQ/PQ, calibration, preventive maintenance, requalification, decommissioning, and data integrity for QC instruments.
  • •Approve stability protocols, reports, annual stability submissions, retention sample requests, shipment excursions, and stability chamber qualification.
  • •Represent QC during internal, external, customer, and regulatory audits; ensure timely closure of incidents and cross-functional impact assessments.
  • •Drive LEAN, Six Sigma, digitization, method transfers, troubleshooting, and collaboration with Manufacturing, QA, Engineering, R&D, and Supply Chain.
  • •Establish departmental performance metrics, communicate technical concepts to stakeholders, and foster a culture of accountability and continuous improvement.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • B.Pharm, M.Pharm, or M.Sc. in Pharmaceutical Analysis, Chemistry, Microbiology, or a related analytical science discipline.
  • Minimum 10+ years of pharmaceutical industry experience with a strong Quality Control laboratory background.
  • Extensive cGMP knowledge covering analytical testing, stability management, lab investigations, equipment qualification, and data integrity.
  • Demonstrated people leadership, performance management, and workforce planning experience for QC teams.
  • Proven audit handling and regulatory inspection experience with FDA, EU, or other global agencies.
  • Hands-on expertise with analytical techniques, QC instrumentation, and troubleshooting methodologies.
  • Strong understanding of incident, CAPA, and change control management within a cGMP environment.

PREFERRED QUALIFICATIONS

  • •Master’s Degree
  • •Statistical Tools and Root Cause Analysis
  • •Environmental Monitoring, Utility Monitoring, Sterility Testing, and Microbial Identification
  • •Method Transfer from R&D to QC
  • •AI Tools such as ChatGPT or Microsoft Copilot for Productivity and Problem-Solving

REQUIRED VERIFIED SKILLS

cGMP Compliance
Quality Control Laboratory Operations
Analytical Testing and Instrumentation
Stability Management
Equipment Qualification (IQ/OQ/PQ)
Data Integrity and ALCOA+
Laboratory Investigations and CAPA
Audit and Regulatory Inspection Readiness
People Leadership and Performance Management
LEAN and Six Sigma Methodologies

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting

ORGANIZATION CONTEXT & CULTURE

Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation. It is dedicated to the discovery, development, manufacturing, marketing, and sale of medicines and vaccines worldwide. The company focuses on breakthrough science to deliver innovative treatments across various therapeutic areas to improve health outcomes.

TEAM SIZE: 80,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare

EXPECTED CAREER ROADMAP

From Group Manager – Quality Control, high performers can progress to Site Quality Head, Head of Quality Control, or Director–Quality Operations within Pfizer’s global network. In 2–3 years, you may lead multi-site QC programs, global method harmonization, or inspection excellence initiatives. In 4–5 years, you could move into Quality Assurance leadership, global quality systems, or manufacturing science and technology roles. India’s pharma market offers strong exit options with Sun Pharma, Dr. Reddy’s, Cipla, Biocon, Lupin, and multinationals like Novartis, Sanofi, and AstraZeneca. Lateral moves into QA, regulatory CMC, validation, or sterile manufacturing leadership are also common for QC leaders with audit and people-management depth.

APPLICATION ADVISORY

Tailor your resume to highlight cGMP QC leadership, team size managed, audit outcomes, and metrics such as right-first-time, deviation closure, and stability cycle time. Prepare STAR examples for FDA/MHRA inspections, lab investigations, CAPA, equipment qualification, and data integrity remediation. Refresh technical knowledge on ICH Q7, Q9, Q10, 21 CFR Part 211, and Annex 1. In interviews, demonstrate risk-based decision-making, method transfer experience, and how you used LEAN or digital tools to improve QC throughput. Mention Pfizer Quality Standards and AI-assisted productivity responsibly.
RECOMMENDED TRAINING
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The Fundamentals of Regulatory Affairs

The Fundamentals of Regulatory Affairs

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