Manager, Quality Auditing-III

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 Manager, Quality Auditing (Contractor) supports the execution and continuous improvement of the global audit program across the Americas and international operations.

Manager, Quality Auditing (Contractor/Consultant)

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 initiatives
Contribute to the development and maintenance of:
oGlobal audit schedules
oApproved supplier lists
oAudit 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
Must Have:
The management team has indicated two areas of experience that are particularly critical for the role:
leading audits in a sterile manufacturing and biologics environment and
software validation and computerized systems compliance