Details:
- Salary: £80,000 - 90,000 - Annum
- Location: Remote work
- Date: 1 month ago
Description:
CK Clinical are recruiting for permanent Associate Director, Clinical QA to join an exciting biotech company in Oxford. You will be needed on-site for one day a week initially but longer term this will be a mainly remote position.
RESPONSIBILITIES:
As Associate Director, Clinical QA you will lead the GCP Quality support for our interventional clinical trials, serve as a GCP Quality expert to the business, and establish strong relationships with the Development & Precision Medicine functions.
Key duties will include:
Provision of expert GCP advice and guidance to project and study teams
Quality review of GCP records
Active contribution to the Quality mission to design & develop a single, fit for purpose QMS
Execution of GCP process, vendor, and investigator site audits
Support GxP Quality needs in Development & Precision functions, e.g. GVP, GLP, GDP/GMP & CSV
Escalation of compliance risks/issues to line managementQUALIFICATIONS:
As Associate Director, Clinical QA you will require:
A relevant life science degree
Extensive GCP experience spanning all phases of clinical development
Expertise in global GCP requirements and guidance, experience of other GxPs would be useful
Experience of performing multiple types of GCP audits
Experience of participating in regulatory authority inspections
BENEFITS:
£80,000-£90,000 plus excellent benefits package.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56604 in all correspondence