Job Description
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.