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