Quality Auditing Manager

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) Position Summary 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. Reporting & Compliance 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., TrackWise or equivalent). Supplier Quality & Stakeholder Partnership 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. #J-18808-Ljbffr Radiant Systems Inc