Associate Director, Clinical QA

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 management

QUALIFICATIONS:
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 correspondenc