Manager, GMP Audits
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Job Description
GMP audit manager at Pfizer, a biopharmaceutical company, leading global manufacturing and distribution audits. Ensuring compliance with GMP/GDP regulations, quality standards, and vendor requirements.
Responsibilities:
- Independently plan, lead, and participate in initial and routine audits of Pfizer manufacturing and distribution operations, license entities, country offices, suppliers, service providers, and commercial/clinical and contract manufacturing sites
- Use AI tools responsibly to support targeted audit preparation and execution
- Engage in complex process audits or review low-complexity outsourced audits
- Support and execute quality programs related to functional areas, vendor entities, and assessments
- Resolve issues using SOPs, GMP/GDP regulations and standards, and local regulations
- Collaborate with RQA colleagues on cross-GxP audit plans
- Manage multiple stakeholders, synthesize feedback, and take action with manager support
- Collaborate with RQA colleagues and auditees across Pfizer and vendor functional lines
- Travel domestically and internationally up to 40% of the time
Requirements:
- BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent
- Extensive expertise in good distribution practices with complex global distribution models, partners and license entities
- Knowledge of MAH and WDA regulatory requirements
- Advanced knowledge and understanding of global regulations, including FDA, ICH, PIC/S, EMA, Health Canada, ANVISA, and TGA
- Knowledge of international standards, including ISO and WHO
- Human oversight, professional judgment, and source verification when using AI tools
- Willingness to adopt new audit technologies and contribute to continuous improvement of digital audit workflows and methodologies
- Comprehensive working knowledge of business concepts and quality operations
- Critical thinking to identify and assess areas of greatest risk and develop strategic audit approaches
- Understanding of quality and auditing frameworks and their application
- Proficient organizational and project management skills
- Technical writing skills
- Ability to identify trends within data and apply insights to make recommendations
- Ability to synthesize information and draw conclusions
- Specialization in at least one conventional technology, such as API or solid oral dosages
- 5–7 years of experience, operational or auditing preferred
- Working knowledge of data analytics and interpretation
- Expertise in vendor audits plus one technology area, such as MDCP, sterile biologics, small molecules, or GDP
- Ability to function autonomously in a matrix model and in a team environment
Benefits:
- Equal opportunity employer
- Remote work assignment
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