Director, Quality (GCP) Location: George Higginson is currently searching for an experienced Director, Quality (GCP), with over a decade of experience in GCP, preferably across Ph. We’re looking for a true leader in GCP Quality to drive strategy and oversight across global clinical programs through Phase II, Phase III, and into commercialisation. You’ll head up a growing QA team and play a key role in shaping quality systems and ensuring inspection readiness in a fast-paced biotech environment.
Lead and develop the GCP Quality team, overseeing strategy, execution, and continuous improvement.
Define and implement GCP Quality oversight across internal functions and external partners.
Ensure inspection readiness and represent QA in global audits (FDA, EMA, MHRA).
Advise on clinical compliance, risk management, and quality system development.
Partner with senior stakeholders to embed a quality-first culture across clinical programs.
10+ years of Clinical Quality Assurance experience with deep GCP expertise across Phase 2 and 3 trials.
~ Global regulatory knowledge (US, EU, UK) and hands-on inspection/audit experience.
~ Experience in risk-based audit planning, vendor oversight, and quality performance monitoring.
~ Bachelor’s degree in life sciences required; Bonus Points For:
Someone who leads by example, motivates teams, and thrives in a dynamic, agile environment.