Quality Specialist Manager

CK Group are recruiting for a Quality Specialist, to join a leading provider of advanced analytics research and technology solutions, to the life sciences industry, at their site based in Paddington for two days, one day in Basildon office and two days working from home, on a contract basis for 12 months.

This role is hybrid.

Salary:
£30.08 per hour PAYE (inside IR35).

Quality Specialist Role:

1. Ensure that all clinical trials are conducted in compliance with regulatory requirements (EMA, MHRA, JFDA, DCGI etc.), ICH-GCP, and applicable national regulations.
2. Monitor adherence to the sponsor company's SOPs, protocols, and standards.
3. Plan, execute, and follow-up on clinical site audits, vendor audits, CRO audits, and internal audits.
4. Prepare detailed audit reports, identify non-compliance issues, and ensure corrective and preventive actions (CAPAs) are implemented.
5. Review and approve clinical trial-related documents, including protocols, informed consent forms, clinical study reports, etc.

Your Background:

1. Minimum 5 years of experience in clinical quality assurance in a CRO or pharmaceutical/biotech company.
2. Detail-oriented and able to work effectively in a team environment.
3. Bachelor's Degree Required.
4. Knowledge of global clinical trial requirements and guidelines.
5. Experience in conducting GCP audits (clinical sites, CROs, vendors, and internal audits).

Company:
Our client offers research services and technology solutions in the life sciences industry. With just under 100,000 employees, the company has operations in over 90 countries worldwide. Our client's ambitions involve optimising results of innovations using artificial intelligence. They believe in utilising data collected to the maximum rather than focussing on gathering lots of information: they use artificial intelligence to do this.

Location:
This role is a hybrid role, it is based at our client's site in Paddington, London and also Basildon.

Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference (Apply online only) in all correspondence.

Please note:
This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.