Job Description
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 up-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:
1. 10+...