Senior GCP Inspection Lead Manager

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

• 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 clinical study teams to build risk-based inspection readiness strategies, manage mock inspections, and develop storyboards with Subject Matter Experts (SMEs
• Live Coordinatio n:
  Strategically orchestrate and assign inspection requests during live audits, providing guidance to ensure accurate, rapid, and bulletproof response
• s.Continuous Quality System s:
  Oversee and enhance vital QA frameworks, including CAPAs, Significant Quality Events (SQEs), deviations, and investigation

• ks.7+ Years of Core GCP QA Experie nce within the pharmaceutical, biotech, or healthcare industri
• es.
  
  Proven "Lead" Track Reco r d:
  You must have definitive experience active l y lead ing major Health Authority inspections, not just supporting from the back offi
• ce.
  
  Diplomatic Toughne ss:
  Strong leadership capabilities to mentor cross-functional partners, hold your ground under pressure, and drive alignment without frict i
• on.
  
  Agility & Flexibili ty: A natural comfort with an unpredictable, rolling, and unannounced worklo
• ad.
  
  Languag es:
  Business fluent written and spoken English.

ingThis is a lean, agile, and fast-moving environment. There is no long onboarding runway—the ideal candidate must be ready to dive straight into live inspections within their first few wee

If you are a results-oriented QA professional with an entrepreneurial mindset and a passion for driving operational excellence, we want to hear from