Manager, Quality Auditing (Contractor)-LC00002

Job Description

Job Description

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

\nCompany Description

Company Description