Blackfield is working with a leading biopharmaceutical company that is pioneering next-generation T-cell therapies for cancer and autoimmune diseases. This organisation is committed to delivering life-changing treatments and fostering a collaborative, inclusive, and development-focused culture.
The successful candidate will plan, execute, and manage a broad range of GCP-focused audits, including internal, investigator site, and vendor audits. This role also includes clinical vendor qualification and lifecycle management, supporting regulatory inspection readiness, and contributing to CQA process improvements. International travel is required up to once per quarter, with local travel to Stevenage approximately once a month.
Key Responsibilities:
* Plan, conduct, and report on international GCP audits, including internal, investigator site, and vendor audits.
* Manage and oversee clinical vendors, including qualification, onboarding, ongoing oversight, and offboarding.
* Maintain and review the risk-based audit plan, track audit metrics, and report compliance risks.
* Support inspection readiness, regulatory inspections, and CQA process improvement initiatives.
* Ensure SOPs are current and aligned with best practices, escalating issues as needed.
The ideal candidate will have a degree in a scientific discipline (life sciences, pharmacy, nursing) or equivalent clinical research/QA experience, with significant experience conducting international GCP audits or working as a regulatory inspector. Experience in vendor qualification and oversight, along with recognised Clinical Research or Clinical Audit qualifications, is needed. A working knowledge of other GxPs such as GMP or GVP, proficiency in data analytics, and experience with GCLP/GVP audits would be advantageous.
If you are interested in this opportunity, please send your up-to-date CV to Oliver@BlackfieldAssociates.com or call Oliver on 02392 314 792.