Quality Assurance Manager

4 days ago


Cambridge, Cambridgeshire, United Kingdom CK Group Full time
{"title": "Quality & Compliance Manager", "description": "Overview

CK Group is seeking a Quality & Compliance Manager to lead the structure, function, and delivery of all quality and compliance activities in a clinical stage biotechnology company in Cambridge.

Responsibilities
  • Maintain the Quality Management System (QMS) and associated activities to ensure compliance with relevant guidelines and regulations.
  • Oversight of Standard Operating Procedure (SOP) preparation, implementation, and training activities.
  • Implement, plan, and coordinate the audit program covering all Research and Development (R&D) activities.
  • Review internal and external Good eXchange Practices (GxP) documentation.
  • Identify and implement process improvements.
Requirements
  • Relevant life science degree.
  • In-depth knowledge of global regulatory and GxP compliance standards.
  • Extensive experience in a regulatory function in an industrial setting.
  • Experience hosting regulatory inspections and QMS management.
  • Excellent written and oral communication skills.
Benefits

Competitive salary and good benefits package.

Hybrid working arrangement in Cambridge.

", "lang_code": "en-US"}

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