Quality Auditing Manager,

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 initiatives
Contribute to the development and maintenance of:
o Global audit schedules
o Approved supplier lists
o 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
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 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
Preferred Qualifications
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