Quality Auditing Manager
Listed on 2026-09-14
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers
Client:
Major Pharmaceutical Client Position:
Quality Auditing Manager Duration: 12 months
Location:
Exton, PA 19341 Pay Rate: $70.00-$75.00/ Hr on W2 Job Description Must-Have Experience
- Leading GMP audits in a sterile manufacturing and biologics environment
- Software validation and computerized systems compliance (CSV/21 CFR Part 11 or equivalent)
The Manager, Quality Auditing (Contractor) supports the execution and continuous improvement of a global quality 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 comply with applicable GMP and regulatory requirements. It is a high-impact, independent position requiring deep GMP expertise, strong auditing experience, and the ability to influence stakeholders across a global network.
The contractor will perform external audits of contract manufacturers (CMOs), laboratories, warehouses, and material/service providers, as well as internal audits of manufacturing and operational sites. Audits may be conducted onsite, remotely, or through desktop reviews.
Key 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 to ensure ongoing GMP compliance and inspection readiness.
- Support execution of the global audit program, including cross-regional audit initiatives.
- Contribute to the development and maintenance of:
- Audit procedures and auditing tools
- Support training and onboarding of global auditors.
- Identify and communicate audit trends, quality risks, and lessons learned.
- Participate in inspection readiness activities and support regulatory inspections (e.g., FDA, EMA) as needed.
- Independently author clear, concise, and timely audit reports.
- Evaluate supplier responses and ensure appropriate follow-up and CAPA closure.
- Maintain audit documentation and quality records within electronic quality management systems (e.g., Track Wise or equivalent).
- Assess supplier suitability and GMP compliance for new and existing partnerships.
- Collaborate with Quality, Manufacturing, and Supply Chain teams to resolve supplier quality issues.
- Provide quality input for supplier selection, qualification, and ongoing supplier oversight.
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