Position: Director, Quality (GCP)
Location: Cambridge, United Kingdom
George 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.
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.
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.
- Bachelor’s 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 We’re 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!
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