Manager, Quality Auditing-III

We are looking for a Quality Auditing professional with strong GMP auditing experience in the pharmaceutical/biotech industry.

Work Model: Hybrid – onsite Monday, Tuesday & Thursday in Exton, PA
Travel: Up to 10% domestic

Role Summary:
Support global audit programs by conducting risk-based audits of CMOs, suppliers, laboratories, warehouses, and internal sites to ensure compliance with GMP and regulatory requirements.

Responsibilities:
• Lead external/internal GMP audits and supplier audits
• Conduct risk-based assessments for CMOs, partners, and vendors
• Support audit planning, execution, reporting, and CAPA follow-up
• Prepare audit reports and maintain audit records in QMS systems (TrackWise or similar)
• Support regulatory inspections (FDA/EMA) and inspection readiness activities
• Partner with Quality, Manufacturing, and Supply Chain teams on compliance matters

Required Skills:
• Bachelor’s degree in Chemistry, Biochemistry, or related field
• 5+ years of GMP auditing experience in pharma/biotech
• Experience leading audits and supporting regulatory inspections
• Strong knowledge of FDA, EU GMP, and ICH guidelines
• Experience with supplier/CMO audits and risk-based auditing
• Strong communication, analytical, and stakeholder management skills

Preferred:
• Biologics/sterile manufacturing audit experience
• ASQ/RABQSA auditor certification
• Experience with computerized systems compliance and supplier lifecycle management