Associate Manager (Quality Assurance – Operations/Compliance/Investigations)

Responsibilities

• Manage, review, and approve Quality Assurance activities including QC documents, batch records, validation protocols, and SOPs.
• Ensure implementation and effectiveness of Quality Management Systems, specifically focusing on Change Control, CAPA, and Deviations.
• Lead deviation investigations using root cause analysis methodologies to ensure robust corrective and preventive actions.
• Drive audit and inspection readiness for internal, corporate, and regulatory inspections (e.g., USFDA, MHRA).
• Provide quality oversight for manufacturing and laboratory operations to ensure adherence to cGMP and global regulatory requirements.
• Provide technical guidance, coaching, and mentoring to junior team members.
• Participate in the Site Change Review Committee to assess critical manufacturing changes.

Requirements

• B. Pharm, M. Pharm, or M.Sc. degree.
• 4–5 years of experience with a Master’s degree, or 6–8 years of experience with a Bachelor’s degree.
• Proven experience in Pharma or Biotech Quality Assurance, Quality Control, Compliance, or Investigations within a sterile dosage manufacturing facility.
• Expertise in Change Management processes and risk assessment principles.
• Knowledge of lab equipment validation and drug product process validations.
• Strong understanding of regulatory guidelines, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP).

Preferred Qualifications

• Experience facing national and international regulatory inspections such as USFDA, MHRA, TGA, or WHO.
• Strong interpersonal and communication skills with the ability to engage effectively across all organizational levels.
• A compliance-driven approach with deep knowledge of cGMP and global regulations.

About the Company

Pfizer is a global leader in the pharmaceutical industry, dedicated to discovering and delivering breakthroughs that change patients' lives. We foster a culture of individual ownership and innovation, seeking talented professionals to join our global community in making the world a healthier place.