Quality Assurance Manager

12 hours ago


Cambridge, Cambridgeshire, United Kingdom University of Cambridge Full time
Quality Assurance Leader

We are seeking a highly skilled and experienced Quality Assurance Leader to join our team at the University of Cambridge. The successful candidate will be responsible for providing leadership on all issues related to GCP and ISO laboratory quality management system.

Key Responsibilities:
  • Provide leadership on GCP and ISO laboratory quality management system
  • Maintain and monitor regulatory compliance of the laboratory to GCP and ISO standards
  • Oversee the quality management system and ensure its effective implementation
  • Manage and administer the Quality Management Information System (Ideagen, previously Q-Pulse)
  • Take on the role of Archivist and maintain an internal and external auditing programme
  • Establish departmental quality meetings and provide guidance and advice to staff and customers on GCP/ISO compliance
  • Assist in the production of remedial action plans as necessary
Requirements:
  • Education to degree level or equivalent in a life science related subject
  • In-depth knowledge of GCP, GCLP, HTA and ISO 15189:2022 regulatory requirements
  • Experience working in a quality assurance setting maintaining a quality management system
  • Experience working in a regulated GCP/ISO service laboratory with clinical trial samples
What We Offer:
  • Training opportunities in quality assurance
  • Opportunities to shadow senior staff in the Cambridge Clinical Trials Unit
  • Opportunities to complete an online Health and Safety course as appropriate for the role

The University actively supports equality, diversity and inclusion and encourages applications from all sections of society. The University has a responsibility to ensure that all employees are eligible to live and work in the UK.



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