GCP QA Manager
GCP QA Manager
I am currently working with an exciting Biotech based in Hertfordshire who are looking for a GCP QA Manager manager to join the team at their state of the art facility.
Reporting to the Head of QA, as GCP QA Manager you will be in a Quality Assurance role that will provide Good Clinical Practice support programmes at clinical-stage programmes through the development, implementation, and execution of global clinical processes and Quality Systems.
GCP QA Manager Responsibilities
- Provide support, guidance, and oversight for clinical studies with focus on compliance with Good Clinical Practice (GCP)'s regulations and guidances.
- Provide expert Good Clinical Practice (GCP) advice and work closely with functional groups to address compliance and quality assurance trends across clinical trials.
- Author, review and/or approve clinical SOPs
- Reviews applicable clinical documents for accuracy and internal consistency as it applies to quality
- Ensure clinical trials are conducted in accordance with protocols, GCP guidelines, and applicable regulatory requirements.
GCP QA Manager Requirements:
- Extensive experience in a QA function, preferably in the pharmaceutical / biotech industry with focus in clinical development and operations.
- QA GCP experience. Minimum of 5 years' experience in pharma / biotech in a GCP role are required
- Excellent knowledge of Clinical Trials Regulations and guidances, including FDA, ICH, WHO, or equivalent.
- Experience and ability to conduct and lead audits.
- Gene therapy experience is a plus , especially in early phase trials.
If this GCP QA Manager role looks like it could be the next step in your career, please get in touch as soon as possible!
To find out more about Real please visit www.realstaffing.com
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