Are you a seasoned GCP Quality Assurance expert who thrives when leading high-stakes health authority inspections? Do you possess the diplomacy, resilience, and operational sharpness to step directly into a fast-paced, live-inspection environment?

We are partnering with an innovative, globally active biopharmaceutical leader with a rapidly accelerating clinical pipeline and commercialized products on the market. They are looking for a Senior Manager, GCP Inspection Lead to join them in an internal, permanent capacity

Reporting to the Senior Director of Global GCP Inspection Management, you will own the frontline defense and preparation for global health authority audit

Responsibilities

• s:Lead HA Inspection s: Serve as the definitive inspection lead for major global bodies (includin g FDA, EMA, MHRA, PM DA, etc.) across sponsor sites, vendors, and NDA-triggered audit
• s.Drive Readiness Strateg y: Partner with cross-functional clinic...