Manager, GMP Audits

About the role

The Manager, GMP Audits leads independent quality audits across Pfizer's global manufacturing and distribution network, ensuring compliance with GxP regulations and internal standards. This remote position requires extensive expertise in GMP/GDP and the ability to leverage AI tools for audit efficiency.

Key responsibilities

• Plan, lead, and execute initial and routine GMP/GDP audits of manufacturing sites, distribution centers, suppliers, and contract manufacturers worldwide.
• Utilize AI‑enabled tools for targeted audit preparation, execution, and reporting while applying professional judgment and source verification.
• Collaborate with cross‑functional RQA teams on audit plans and support quality programs for specific vendors and assessments.
• Identify risk trends, synthesize stakeholder feedback, and drive continuous improvement of audit methodologies.

Required profile

• BS in pharmaceutical, natural sciences or related field.
• 5‑7 years of operational or auditing experience in a global pharmaceutical environment.
• Deep knowledge of GMP/GDP regulations (FDA, EMA, ICH, ANVISA, TGA, etc.) and international standards (ISO, WHO).
• Strong analytical, technical writing, and project management skills.

Required skills

• Good Distribution Practices (GDP) expertise.
• GMP audit execution and regulatory compliance.
• Data analytics and interpretation.
• Proficiency with AI tools for audit planning and reporting.