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Senior Team Leader - Mfg. Compliance

6-8 years
₹12 – ₹18 LPA
10 Aug. 10, 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

Senior Team Leader – Manufacturing Compliance

📍 Location: Vizag, India (On-site)
🕒 Experience: 6–8+ Years (Sterile Pharma Manufacturing, cGMP, Regulatory Compliance)
💼 Industry: Pharmaceutical Manufacturing / Quality & Compliance / Regulatory Affairs
🏢 Company: Pfizer

Salary: ₹12 – ₹18 LPA (Estimated based on experience and Vizag pharma industry benchmarks)


About the Role:

Pfizer is hiring a Senior Team Leader – Manufacturing Compliance at its Vizag facility to oversee quality systems, regulatory compliance, and manufacturing documentation in a sterile pharmaceutical environment. You will lead a team to ensure cGMP adherence, inspection readiness, and operational excellence, directly contributing to Pfizer’s mission of delivering safe, effective, and high-quality medicines worldwide.


Key Responsibilities:

  • Lead downstream manufacturing compliance activities.

  • Maintain Quality Management Systems in alignment with cGMP and global regulatory requirements.

  • Manage the Change Control Management System, including impact assessments, approvals, and closure tracking.

  • Coordinate CAPA identification and implementation to address investigation findings.

  • Review and approve Master Manufacturing Records for commercial, scale-up, exhibit, and validation batches.

  • Oversee quality risk assessments for equipment and processes.

  • Ensure compliance with audit observations and track action item implementation.

  • Monitor training compliance for all production staff, ensuring no overdue items.

  • Review compendial assessments, APQR, trend reports, and deviation closures.

  • Facilitate documentation issuance, retrieval, and control in coordination with QA and production teams.

  • Support inspection readiness by monitoring regulatory commitments and action items.

  • Conduct gap assessments and implement corrective actions for regulatory requirements.

  • Drive SOP compliance, quality systems adherence, and safety system implementation.

  • Lead responses to market complaints, identify root causes, and implement CAPA.

  • Manage and develop team members, including performance evaluations and coaching.


Qualifications & Experience Required:

  • Postgraduate in Science/Pharmacy with 6+ years OR B.Pharm with 8+ years in quality and compliance roles in sterile manufacturing.

  • Proven experience preparing for FDA, EMA, or other regulatory inspections.

  • Strong project management skills and ability to handle multiple priorities.

  • Proficiency in Microsoft Office tools.

  • Excellent written and verbal communication skills.

  • Strong problem-solving abilities with a customer-focused mindset.


Preferred Skills:

  • Experience in people management and leadership roles.

  • Deep knowledge of pharmaceutical quality systems.

  • Strong negotiation and influencing skills.

  • Strategic thinking and ability to advise on enterprise initiatives.

  • Proven track record of driving compliance and inspection readiness programs.


What Pfizer Offers:

  • Competitive salary and performance incentives.

  • Comprehensive health and insurance benefits.

  • Leadership development opportunities in a global organization.

  • Inclusive and diverse workplace culture.


Join Pfizer as a senior leader in manufacturing compliance and ensure the highest quality standards in life-saving medicines.