QA Manager, Audit and Inspection Management

The Quality Assurance Manager, Audits & Inspections leads the planning, execution, and continuous improvement of the company's GxP audit and regulatory inspection readiness programs for late-stage pharmaceutical development. This hands-on role supports internal, external, vendor, and study-related audits while establishing sustainable inspection-readiness initiatives as the organization advances through Phase 3 clinical development toward regulatory submission and commercialization. The position partners with cross-functional teams to identify compliance risks, manage audit observations, and ensure readiness for FDA and other health-authority inspections.