Manager Compliance India - Ahmedabad

About the Role

Manager Compliance India will oversee quality assurance compliance at the ZHOPL site, ensuring GMP compliance for Pfizer products manufactured there in alignment with Pfizer quality agreements. What You'll Do

• Maintain overall quality assurance compliance at ZHOPL and ensure sustainable GMP compliance for Pfizer products as per the quality agreement.

• Review and authorize packed batch records and release for distribution from ZHOPL; participate in SQRT for batch-related issues.

• Conduct regulatory impact assessments for changes to Pfizer products; review and approve Change controls at ZHOPL per Pfizer requirements.

• Perform Site Compliance Network Member (SCNM) activities and create PAC and PCF in the PDM systems.

• Review and approve submission packages as per REG-459; review BoH queries and data changes.

• Review and approve NPL assessments and dossier handovers to ZHOPL; manage Pfizer product complaint handling and approve investigation reports uploaded to the Pfizer electronic complaint database.

• Coordinate committee meetings; share applicable information/distribution details to site and Pfizer market action leader during market actions and mock recalls.

• Ensure QMS compliance: review/approve Investigations (QARs) at ZHOPL; participate in SQRT; support supplier management; assist with document reviews for new product launches and tech transfers; review process validation activities at ZHOPL.

• Provide coverage for urgent activities as assigned; support AQRT/ESQRT processes as required; participate in Pfizer SOPs management activities as LPO for processes. What We're Looking For

• B. Pharm / M. Pharm / M.Sc.

• 10+ years of pharmaceutical industrial experience

• Exceptional organizational and project management skills

• Strong analytical abilities with meticulous attention to detail

• Solid understanding of regulatory and audit frameworks in biopharmaceutical operations

• Ability to act decisively based on quality and compliance metrics and trends

• Capable of managing multiple complex projects with strong business acumen

• Excellent interpersonal, written, and verbal communication skills Nice to Have

• Master’s degree

• Experience in aseptic processes and operational knowledge

• Knowledge of training design and tools; experience applying training methodologies

• Ability to adapt to changing priorities and manage multiple tasks

• Experience using AI tools (e.g., ChatGPT, Microsoft Copilot) to support problem solving and productivity

• Curiosity about responsible AI practices, risk management, and ethical use Compensation & Benefits

• Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.