GMP Audits Manager

About the role

The Regulatory Quality Assurance (RQA) team at Pfizer seeks a Manager to lead GMP/GDP audits across manufacturing, distribution, and partner sites worldwide. This senior position is remote‑based but requires frequent travel to audit locations.

Key responsibilities

• Plan, lead, and execute initial and routine GMP/GDP audits of Pfizer sites, license entities, suppliers, and contract manufacturers.
• Utilise AI tools to enhance audit preparation, execution, and reporting while maintaining professional judgment.
• Collaborate with cross‑functional RQA colleagues on integrated GxP audit plans.
• Identify high‑risk areas, synthesize stakeholder feedback, and drive corrective actions.

Required profile

• Bachelor’s degree in pharmaceutical, natural sciences or related field.
• 5‑7 years of operational or auditing experience in GMP/GDP environments.
• Strong knowledge of global regulations (FDA, ICH, EMA, ANVISA, TGA, etc.) and standards (ISO, WHO).
• Ability to work autonomously in a matrix organization and manage multiple stakeholders.

Required skills

• Good Distribution Practices (GDP) expertise.
• GMP audit methodology.
• Proficiency with AI‑enabled audit tools.
• Data analytics and interpretation.
• Technical writing for audit reports.