Manager, GMP Audits

• 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

• 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

• Equal opportunity employer
• Remote work assignment