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Manager, Quality Auditing-III

Integrated Resources, Inc

  • Exton, PA
  • 2 days ago

    Highlights

    This is a high-impact, independent role requiring deep GMP expertise, strong auditing experience, and the ability to influence stakeholders across a global network. Position Summary The Manager, Quality Auditing (Contractor) supports the execution and continuous improvement of the global audit program across the Americas and international operations.

    Numbers & Facts

    LocationExton, PA

    Description

    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

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