Senior Quality Assurance Manager (Clinical)

Job Overview

Our Client a leading CRO is a full service clinical development organisation performing all aspects of clinical trials. They are a dynamic, proactive multicultural CRO, offering a high quality, customised and flexible service.

Position

Due to continued success our client now has an exciting opportunity for a Senior Quality Assurance Manager to join their QA department.

About the Role

The Quality Assurance Manager (QAM) will assist the head of Quality Assurance with the implementation and maintenance of QA programs.

Scheduling and conducting audits both internally and externally, producing reports following all audits and follow up resolutions, and inspecting preferred vendor facilities.

Qualifications & Experience

Successful candidate will have a Science/health degree with proven knowledge of GCP and a track record in Quality Assurance within an ICH GCP environment or clinical research discipline, either in a CRO or pharmaceutical industry. Proven experience as a GCP Auditor.

Audit Experience

• Investigator sites
• Data management
• Clinical study reports
• Computer systems for 21 CFR Part 11 compliance
• Internal system audits

Additional Requirements

Aware of GxPs relevant to the conduct of a clinical trial and capable of multi tasking. Proficient computer skills and willingness to travel internationally and within the UK.

Compensation and Location

Salary 35 - 40K Approx. Location: Thames Valley, Berkshire.

How to Apply

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