Manager GMP Audits

About the role

The Manager GMP Audits leads independent quality audits across Pfizer's manufacturing and distribution operations worldwide, ensuring compliance with global GMP/GDP regulations and Pfizer Quality Standards.

Key responsibilities

• Plan, lead and execute audits of manufacturing, distribution sites, license entities, suppliers and service providers.
• Utilize AI tools for targeted audit preparation and execution.
• Engage in complex process audits and review outsourced audit reports.
• Support quality programs and resolve issues based on SOPs, regulations and standards.
• Collaborate with cross‑functional RQA teams and manage stakeholder feedback.

Required profile

• BS in pharmaceutical, natural sciences or equivalent.
• 5‑7 years of operational or auditing experience, preferably in pharma.
• Extensive knowledge of GMP/GDP regulations (FDA, EMA, ICH, etc.) and international standards.
• Strong analytical, critical‑thinking and technical writing abilities.
• Ability to travel up to 40% internationally.

Required skills

• Good Distribution Practices (GDP) expertise.
• GMP audit methodology.
• Use of AI tools for audit processes.
• Data analytics and interpretation.