Manager, Quality Auditing-III

Manager, Quality Auditing

Location:

Exton PA Duration: 12+ Months Pay Range: $45/hr.

- $51/hr.

The Manager, Quality Auditing 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.

• 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 initiatives
• Contribute to the development and maintenance of: global audit schedules, approved supplier lists, audit procedures and tools
• Support training and onboarding of global auditors
• Identify and communicate trends, risks, and lessons learned from audit findings
• Participate in inspection readiness activities and support regulatory agency inspections (e.g., FDA, EMA) as needed

• 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., Track Wise or equivalent)

• 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

• 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 and/or supporting regulatory inspections
• Strong knowledge of global GMP regulations and guidelines (FDA, EU, ICH)
• 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
• Travel:
  Up to 10% (domestic)
• Work model:
  Hybrid – onsite presence (Exton, PA) required Monday, Tuesday, and Thursday when not traveling

• Experience auditing biologics and sterile manufacturing operations
• Auditor certification (e.g., ASQ, RABQSA, or equivalent)
• Experience with software validation and computerized systems compliance
• Familiarity with supplier lifecycle management and risk-based audit strategies
• Experience working in a global, cross-functional environment