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 (phone number removed) in all correspondence