Manager, Quality Auditing (Contractor)-LC00002

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

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