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Quality Assurance Manager

2 months ago

Cambridge, United Kingdom CK Group- Science, Clinical and Technical Full time

Job Summary:

CK Group- Science, Clinical and Technical is seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for ensuring the quality and compliance of our products and services.

Key Responsibilities:

  • Maintain and improve the quality management system (QMS) to ensure compliance with relevant guidelines and regulations.
  • Oversee the development and implementation of standard operating procedures (SOPs) and training programs.
  • Coordinate and lead audits of research and development activities, from preclinical to clinical and commercial manufacturing.
  • Review and approve internal and external documentation, including protocols, investigator brochures, and informed consent forms.
  • Identify and implement process improvements to enhance quality and efficiency.

Requirements:

  • Relevant life science degree.
  • In-depth knowledge of global regulatory and quality compliance standards.
  • Extensive experience in a regulatory function in an industrial setting.
  • Experience hosting regulatory inspections and QMS management is highly desirable.
  • Excellent written and oral communication skills and ability to interact effectively with colleagues.

Benefits:

  • Competitive salary range: £70,000-£80,000.
  • Good benefits package.