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Permanent

Associate Director, Clinical Quality Assurance

Hatfield
money-bag 10000-500000 Annual
3057095958
Posted 3 days ago

CK Group are recruiting an Associate Director, Clinical Quality Assurance, for a leading global pharmaceutical company. This hybrid role requires three days per week in their Home Counties office.The Role:As Associate Director, Clinical Quality Assurance, you will oversee GCP activities in-house, with CROs and at Investigator sites, lead GCP audits and manage inspection activities, ensuring the highest standards of quality compliance in all aspects of clinical research. Responsibilities:Acting as CQA Lead for clinical studies, drafting and managing Audit Plans and Reports.Performing Clinical Investigator Site Audits, GCP Document Audits, Internal Process Audits and Vendor / System Audits.Leading regulatory authority inspection activities. Facilitating ongoing quality improvement.Representing the CQA group in internal meetings.Providing GCP training sessions for business groups.Your Background:A relevant BSc.Strong Clinical Quality Assurance experience.Experience of performing internal and external audits and of hosting regulatory authority inspections.An in-depth knowledge of international regulations and guidelines for the conduct of clinical trials.Strong interpersonal skills.Ability to travel up to 25%.Salary: Competitive salary plus an excellent benefits package. Apply: It is essential that applicants hold entitlement to work in the UK. Please quote job reference (phone number removed) in all correspondence.

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