GxP Quality Auditor

Job Summary

Reporting to the Audits Director, the full-time Associate Director, GxP Quality Auditor will plan and conduct quality audits, serve as a Subject Matter Expert in GxP auditing, and support the implementation of the Quality Management Auditing system, all in a remote capacity.

Key responsibilities

• Function as a Quality/GxP auditor for external CDMOs, clinical sites, and internal laboratory operations
• Implement the global audit strategy in alignment with organizational goals and regulatory requirements
• Prepare comprehensive audit reports and facilitate post-audit debriefs with internal stakeholders

Required qualifications

• Minimum bachelor's degree in any scientific discipline
• 5-7 years of biopharmaceutical experience, including at least 3 years of GxP auditing in a regulated environment
• Excellent knowledge of GxP regulatory requirements
• Experience with electronic Quality Management Systems
• Auditor certification is preferred