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Group Manager - Compliance & Investigations

10+ years
₹40–50 LPA
10 Aug. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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)