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Manager, Quality Auditing-III

Integrated Resources, Inc
  • Exton, PA
  • Instant Apply
8 days ago

Job 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

Numbers & Facts

LocationExton, PA

Skills

  • American Society for Quality (ASQ)unmatched
  • Analysis Skillsunmatched
  • Auditingunmatched
  • Biochemistryunmatched
  • Biotech and Pharmaceuticalunmatched
  • CMOSunmatched
  • Chemistryunmatched
  • Clinical Supportunmatched
  • Communication Skillsunmatched
  • Continuous Improvementunmatched
  • Contract Manufacturingunmatched
  • Cross-Functionalunmatched
  • Desktop PCunmatched
  • Detail Orientedunmatched
  • External Auditunmatched
  • FDA (Food and Drug Administration)unmatched
  • GMP (Good Manufacturing Practices)unmatched
  • ICH Regulationsunmatched
  • Internal Auditunmatched
  • International Operationsunmatched
  • Laboratoryunmatched
  • Leadershipunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Manufacturing Auditunmatched
  • Medical Productsunmatched
  • Multitaskingunmatched
  • Onboardingunmatched
  • Presentation/Verbal Skillsunmatched
  • Problem Solving Skillsunmatched
  • Quality Managementunmatched
  • Regulationsunmatched
  • Regulatory Requirementsunmatched
  • Riskunmatched
  • Software Validationunmatched
  • Supply Chainunmatched
  • Time Managementunmatched
  • Trend Analysisunmatched
  • Vendor/Supplier Evaluationunmatched
  • Vendor/Supplier Selectionunmatched
  • Warehousingunmatched
  • Willing to Travelunmatched
  • Writing Skillsunmatched

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