Title: Manager, Quality Auditing-III
Location: Exton, PA- Hybrid
Duration: 12 Months+ Possible Extension
Travel: Up to 10% (domestic)
Work model: Hybrid – Onsite presence (Exton, PA) required Monday, Tuesday, and Thursday when not traveling
Position Summary
- The Manager, Quality Auditing (Contractor) supports the execution and continuous improvement of the global audit program across the Americas and international operations.
- This role is responsible for conducting risk-based audits and ensuring that suppliers, partners, and internal sites meet applicable GMP and regulatory requirements.
- This is a high-impact, independent role requiring deep GMP expertise, strong auditing experience, and the ability to influence stakeholders across a global network.
- The contractor will conduct external audits of contract manufacturers (CMOs), laboratories, warehouses, and material/service providers, as well as internal audits of company sites. Audits may be performed onsite, remotely, or via desktop review.
Responsibilities
- Audit Program Support, Execution & Oversight
- Lead and perform risk-based external audits of CMOs, laboratories, warehouses, and suppliers supporting commercial and clinical products
- Conduct internal audits of company sites to ensure ongoing GMP compliance and inspection readiness
- Support global audit program execution, including cross-regional audit initiative
Contribute to the development and maintenance of:
- Global audit schedules
- Approved supplier list
- Audit procedures and tools
- Support training and onboarding of global auditors
- Identify and communicate trends, risks, and lessons learned from audit finding
- Participate in inspection readiness activities and support regulatory agency inspections (e.g., FDA, EMA) as needed
Reporting & Compliance
- Independently author clear, concise, and timely audit reports.
- Evaluate supplier responses and ensure appropriate follow-up and closure
- Manage audit-related records in quality systems (e.g., TrackWise or equivalent)
Supplier Quality & Stakeholder Partnership
- Assess supplier suitability and GMP compliance for new and existing partnerships
- Partner with Quality, Manufacturing, and Supply Chain stakeholders to resolve supplier quality issues
- Provide quality input for supplier selection, qualification, and ongoing oversight
Requirements
- Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline
- Minimum 5+ years of GMP auditing experience in pharmaceutical or biotechnology environments
- Demonstrated experience leading audits in sterile manufacturing and biologics environments required.
- Strong knowledge of global GMP regulations and guidelines (FDA, EU, ICH)
- Experience with software validation and computerized systems compliance
- Proven ability to independently assess compliance and make risk-based decisions
- Excellent written and verbal communication skills
- Strong analytical and problem-solving capabilities
- High attention to detail with the ability to manage multiple priorities
- Ability to influence and collaborate across functions and geographies
- Demonstrated independence, sound judgment, and professionalism
Preferred Qualifications
- Experience supporting regulatory inspections
- Auditor certification (e.g., ASQ, RABQSA, or equivalent)
- Familiarity with supplier lifecycle management and risk-based audit strategies
- Experience working in a global, cross-functional environment