Audit Lead
Skills
ASQBiotechnologyContinuous ImprovementData AnalyticsData IntegrityISO StandardsInterviewing
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- Bachelor’s degree in pharmaceutical sciences or equivalent
- Required 10 years of progressive experience in pharmaceutical biopharmaceutical or medical device quality manufacturing or GMP/GDP auditing
- Aseptic manufacturing experience and/or expertise
- Required GMP/GDP auditing experience across at least 3 technology areas
- Strong knowledge of Quality Management Systems and GMP/GDP requirements
- Familiarity with global regulations and standards including FDA EU Directive ICH TGA PIC/S and ISO
- Ability to perform critical analysis identify risk and recommend solutions
- Ability to lead diverse audit teams and work across multicultural environments
- Strong business leadership relationship and technical skills including negotiation technical writing and data analytics
- Ability to travel up to 40 percent domestically and internationally
- U.S. permanent work authorization required
Nice to have
- Master's degree
- Audit certification
- Site internal audit experience
- Shop floor QA experience
- BoH experience
- Notified Body experience
- Medical device regulation knowledge
- Cross-region project leadership
Day to day
- Lead the design delivery and maintenance of GMP/GDP audit strategy for a complex technology or business area with a strong focus on aseptic sterile biologics and biotechnology.
- Plan and execute independent audits inspection preparation activities and ad hoc assessments across Pfizer facilities contract manufacturers suppliers and service providers.
- Partner with RQA PGS PharmSci Site Quality and global stakeholders to identify emerging risks improve quality systems coach auditors and drive continuous improvement.