Manager, Quality Auditing-III

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