Associate Director – GCP Quality Assurance (EU/UK)
Remote from Europe (must have very strong proficiency in English)
We’re supporting a global, clinical-stage biotech with an expanding oncology pipeline and increasing regulatory activity across Europe. This is a high-visibility QA role focused on GCP oversight across EU/UK clinical programs, with direct exposure to late-stage development and inspection readiness.
The Role
Reporting into senior QA leadership, you’ll take ownership of GCP Quality Assurance across European clinical activities, partnering closely with Clinical Ops, PV and broader development teams.
Key responsibilities include:
* Leading GCP QA strategy across EU/UK clinical programs
* Conducting site, vendor and CRO audits (routine & for-cause)
* Driving risk-based audit planning and execution
* Supporting inspection readiness and pre-approval inspections
* Managing deviations, CAPAs and quality investigations
* Partnering cross-functionally to ensure GCP compliance across trials
* Acting as a key QA voice in global clinical development activities
What They’re Looking For
* 7+ years’ experience in GCP QA within biotech/pharma
* Strong background in clinical trial auditing (sites & vendors)
* Experience supporting late-stage clinical programs
* Exposure to health authority inspections / inspection readiness
* Strong understanding of GCP regulations and global standards
* Ability to operate in a hands-on, collaborative environment