QA Compliance Manager

CK Group are looking for a Quality & Compliance Manager to join a clinical stage biotechnology company in Cambridge.

Our Client has established a leadership position in the enzymes field. These enzymes are now emerging as attractive therapeutic targets as they are involved in many disease pathways and pathologies.

RESPONSIBILITIES:

As Quality & Compliance Manager you will have responsibility for the structure function and delivery of all quality and compliance activities in the company, including GxP compliance.

• Maintenance of the QMS and associated activities to ensure compliance with all relevant guidelines and regulations, including GxP.
• Oversight of SOP preparation and implementation and training activities.
• Implementing, planning and coordinating the audit program covering all R&D activities, from preclinical through to clinical and CMC.
• Review of internal and external GxP documentation, such as Protocols, Investigator Brochures and Informed Consent Forms.
• Proactive identification and implementation of process improvements.

QUALIFICATIONS:

As Quality & Compliance Manager you will require:

• A relevant life science degree.
• An in-depth knowledge of global regulatory and GxP compliance standards.
• Extensive experience in a regulatory function (eg Clinical Research or CMC) in an industrial setting.
• Experience of hosting regulatory inspections and of QMS management would be very useful.
• Excellent written and oral communication skills and the ability to interact effectively with a wide range of colleagues.

BENEFITS:

£70,000-£80,000 plus good benefits.

Location:

Hybrid, Cambridge.


Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 106495 in all correspondence.