GCP QA Manager in Cambridge
Jim Gleeson is recruiting for a GCP QA Manager for a permanent position with an exciting commercial stage biotechnology company. The role will be office based in Cambridge.
Your role will be to contribute to develop, execute and maintain risk-based audit strategies focused on internal and external Good Clinical Practice audits to ensure that all clinical trial activities are compliant with ICH-GCP, local applicable regulations and company procedures.
Key Responsibilities will include:
- Execution of audits of internal processes, external vendors and Investigator Sites.
- Identification and escalation of GCP corporate risk and serious non-compliance situations.
- Review of documents such as Clinical Trial Protocols, regulatory submissions, CAPAs etc prior to Quality Assurance approval.
- Represent GCP Quality Assurance on compliance related projects and initiatives, leading them when appropriate.
- A relevant life science degree.
- Extensive GCP quality assurance experience gained within a pharmaceutical company or CRO.
- Proven auditing and regulatory authority inspection experience.
- Ability to compile and interpret quality metrics
- Strong influencing and negotiation skills.- The ability to travel up to 40%.
For more information or to apply for this position, please contact Jim Gleeson on 01438 842973 or Sam Whyley-Smith on 01246 580040 or email email@example.com / firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45893 in all correspondence.