Position: Director, Quality (GCP)Location: Cambridge, United KingdomGeorge Higginson is currently searching for an experienced Director, Quality (GCP), with over a decade of experience in GCP, preferably across Ph. II and Ph. III, with an-and-coming clinical-stage Biotech, developing a ground-breaking nanobody for Inflammatory Diseases. Were 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. Youll 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.Main Responsibilities: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.Requirements:10+ years of Clinical Quality Assurance experience with deep GCP expertise across Phase 2 and 3 trials.Strong leadership background, with proven experience managing teams and driving strategy.Global regulatory knowledge (US, EU, UK) and hands-on inspection/audit experience.Experience in risk-based audit planning, vendor oversight, and quality performance monitoring.Bachelors degree in life sciences required; advanced degree preferred.Bonus Points For:Experience with GMP as applied to clinical development.Background in Biologics.Involvement in BLA or MAA submissions.What Were Looking For:A strategic thinker and hands-on leader.Someone who leads by example, motivates teams, and thrives in a dynamic, agile environment.A communicator who can influence at all levels, internally and externally.This is a fantastic opportunity to be a key part of a true-underdog clinical-stage Biotech, soon approaching a BLA submission.Apply today to take the next step in your leadership journey!
Job Title
Director, Quality