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Quality Assurance Manager

2 months ago

Cambridge, United Kingdom CK Group Full time

CK Group is seeking a Quality Assurance Manager to join our team in Cambridge. As a leading provider of scientific and technical services, we are committed to delivering high-quality solutions to our clients.

The successful candidate will have responsibility for ensuring the quality and compliance of our services, including GxP compliance. This will involve:

  • Maintenance of our Quality Management System (QMS) and associated activities to ensure compliance with all relevant guidelines and regulations.
  • Oversight of Standard Operating Procedure (SOP) preparation and implementation, as well as training activities.
  • Implementation, planning, and coordination of the audit program covering all research and development activities.
  • Review of internal and external GxP documentation, such as protocols, investigator brochures, and informed consent forms.
  • Proactive identification and implementation of process improvements.

The ideal candidate will have:

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

Benefits:

Competitive salary and benefits package

Hybrid working arrangement