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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.
