Director, GCP Quality (Biotech)

TL;DR

Director, GCP Quality (Biotech): Providing strategic leadership and oversight of clinical quality systems and audit programs for a mental health biotechnology company with an accent on regulatory compliance, data integrity, and inspection readiness. Focus on designing risk-based GCP QA functions, managing complex compliance scenarios, and ensuring adherence to global regulatory requirements (FDA, EMA, ICH).

Location: Home-based or hybrid in London, UK. Must have existing employment rights in the UK.

Company

Biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, focusing on novel treatments for treatment-resistant depression and PTSD.

What you will do

• Define and execute global GCP QA strategy aligned with clinical development objectives.
• Establish and improve GCP QA processes, including deviations, CAPA, and change control.
• Lead a risk-based audit program covering investigator sites, CROs, and vendors.
• Manage inspection readiness and act as the key Quality representative during regulatory inspections.
• Assess compliance risks related to subject safety and data integrity.
• Develop and implement a fit-for-purpose GCP training strategy to build internal capabilities.

Requirements

• 15+ years of experience in clinical quality assurance within the pharmaceutical or biotech industry.
• Extensive experience across the full clinical development lifecycle (Phase I–IV).
• Deep knowledge of international GCP regulations and guidance (FDA, EMA, ICH).
• Proven track record in managing regulatory inspections and complex vendor oversight.
• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• Must have employment rights in the UK (sponsorship is not available).

Culture & Benefits

• Commitment to diversity, equality, and providing reasonable accommodations.
• Opportunity to work on pioneering treatments for mental health conditions.
• Flexible work arrangements (Home-based or hybrid in the London office).