Associate Director, GCP Quality Assurance
Jim Gleeson is recruiting for an Associate Director, Clinical Quality Assurance to join an innovative biotech with a very promising lead candidate in a Phase II program with others in Phase I. This will be an office based role in Oxford.
As Associate Director, Clinical Quality Assurance your role will be to ensure compliance with all relevant GxP guidelines and national and international regulations across all development activities.
Key duties will include:
- Responsibility for the Quality Management System, ensuring that it's fully up to date and compliant at all times
- Taking a lead on all clinical quality matters relating to regulatory submissions, clinical protocols and the conduct and reporting of clinical trials
- Review and management of quality events, OOS, audit non-conformances, CAPAs and quality agreements
- Management, coordination and performance of internal and external GxP audits
- Monitoring of risk assessment plans for clinical studies
- Contribution to the selection of and ongoing auditing of key suppliers, vendors and CROs
As Associate Director, Clinical Quality Assurance you will require the following:
- A life science degree
- Extensive GCP quality management experience gained in a biotech or pharmaceutical company, including the development and maintenance of QMS
- GMP and GPvP experience will be advantageous
- Experience of performing on-site audit of suppliers and Investigator Sites- Strong project management, communication and interpersonal skills
- The ability to work in a fast paced small company environment whilst remaining creative and dynamic
For more information or to apply for this position, please contact Jim Gleeson on 01438 842973 or via email on email@example.com. 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 47486 in all correspondence.