GCP QA Manager
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, butwith some home working possible.
Salary:
Base around £65K with a good benefits package.
RESPONSIBILITIES:
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
QUALIFICATIONS:
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
Apply:
Entitlement to work in the UK is essential. For more information please contact Jim Gleeson on 01438 842973 or email jgleeson@ckclinical.co.uk. Please quote reference 50306 in all correspondence.
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