Job Description
Jim Gleeson is recruiting for an Associate Director, Clinical Quality Assurance to join a well-established and successful global pharmaceutical company. This will be a hybrid role, three days a week in their Home Counties offices.
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:
1. A relevant BSc.
2. Strong Clinical Quality Assurance experience.
3. Experience of performing internal and external audits and of hosting regulatory authority inspections.
4. An in-depth knowledge of international regulations and guidelines for the conduct of clinical tria...