Job Title: Group Manager – Compliance & Investigations
Location: Visakhapatnam, India
Employment Type: Full-time | On Premise
About the Company:
Pfizer is a global leader in pharmaceuticals, committed to breakthroughs that change patients’ lives. Pfizer Global Supply (PGS) manufactures and distributes high-quality medicines worldwide, ensuring strict compliance with cGMP and regulatory requirements.
Role Overview:
The Group Manager – Compliance & Investigations partners with the Engineering Lead to uphold engineering compliance, conduct investigations, and drive a proactive quality culture. This role ensures adherence to cGMP, cGEP, and Pfizer Quality Standards while leading audits, managing quality metrics, and implementing continuous improvement initiatives across engineering operations.
Key Responsibilities:
Compliance Management
Ensure adherence to quality systems, safety protocols, and regulatory guidelines.
Review and approve change controls, documents, and SOPs.
Support root cause analysis, CAPA implementation, and timely closure of quality records.
Maintain audit readiness and ensure timely resolution of observations.
Implement Pfizer Quality Standards (PQS) and ensure training completion.
Investigation Management
Lead investigations into equipment failures and non-conformances using tools such as 5 Whys, Fishbone diagrams, Pareto analysis, and FMEA.
Monitor and trend deviation data to identify systemic issues and compliance risks.
Translate investigation insights into actionable improvement projects.
Coach teams on best practices and institutionalize lessons learned.
Audits, Assessments & Walkthroughs
Lead GMP, GDP, and GEP compliance audits and site walkthroughs.
Identify and address gaps, ensuring regulatory alignment.
Develop Subject Matter Experts (SMEs) through coaching.
Enterprise Asset Management System (EAMS)
Define functional requirements, manage user setup, and oversee spare parts planning.
Lead EAMS projects, reviews, and upgrades.
Ensure data accuracy, monitor system performance, and liaise with vendors.
Maintenance Oversight
Ensure timely completion of planned maintenance work orders.
Monitor execution to mitigate compliance risks.
Process Improvement & Reporting
Drive continuous improvement projects that enhance quality and compliance.
Prepare and review MIS reports, track site quality metrics, and trend failures/breakdowns.
Culture & Leadership
Act in line with Pfizer’s core values: Courage, Equity, Excellence, and Joy.
Promote health, safety, and environmental standards.
Provide leadership, feedback, and growth plans to the team.
Qualifications – Minimum Requirements:
Bachelor’s degree in a technical discipline.
10+ years of experience in the pharmaceutical industry.
Strong knowledge of audits, compliance systems, and engineering processes.
Excellent leadership, stakeholder management, and conflict resolution skills.
Strong organizational and multitasking abilities.
Work Location Assignment: On Premise
Estimated Salary: ₹40–50 LPA (Based on senior compliance leadership roles in multinational pharma companies in India)
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