Jim Gleeson is recruiting for a GCP QA Manager to join an innovative biotechnology company with a strong gene therapy pipeline in pre-clinical and clinical development as well as approved treatments. The role will be based at their London office, but with some home working possible.
Base around £65K with a good benefits package.
As GCP QA Manager you will work closely with the GCP QA Director to provide Quality and Compliance support across all clinical research activities, internal and external.
Key duties will include:
- Acting as Clinical Compliance Lead for assigned clinical trial programs
- Leading development of relevant audit plans for assigned projects and manages audit plan execution
- Managing and/or leading and following up GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors
- Working closely with clinical study management teams to provide expert clinical compliance information, managing identified issues, and supporting continuous improvement
- Evaluating, writing and/or reviewing operating procedures (e.g. SOPs), and performs other activities in support of an integrated cross-functional quality management system (QMS)
- Assisting in inspection readiness preparation, and/or directly supporting regulatory agency inspection
As GCP QA Manager you will require:
- A relevant life science degree
- Industrially based (ideally biotech) experience of performing internal and external GCP audits
- Experience of managing audit and CAPA management programmes
- Very strong communication and interpersonal skils
- Ability to travel up to 30%
- Ideally have experience of working with advanced therapies
Entitlement to work in the UK is essential. For more information please contact Jim Gleeson on 01438 842973 or email firstname.lastname@example.org. Please quote reference 50306 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Jim Gleeson
- Phone: 01438 743 047
- Reference: 50306
Website: CK Group
- Posted: 1st April 2021
- Expires: 29th April 2021