Quality Management System Lead

5 days ago


Cambridge, Cambridgeshire, United Kingdom Blackfield Associates Full time

Cambridge-based Blackfield Associates is searching for a Quality Assurance Manager to lead its quality systems towards excellence. The ideal candidate will have a proven track record in implementing and managing Quality Management Systems, ensuring compliance with current Good Manufacturing Practices (cGMP) in line with EU and FDA requirements.

Responsibilities include:

  • Managing the Quality Management System (QMS) as a senior member of the QA Team, including supplier management, internal audits/self-inspections, stability programs, change control, deviations, investigations, corrective actions, and risk management.
  • Hosting and supporting audits conducted by customers and regulatory bodies.
  • Providing training sessions on QMS and cGMP topics.
  • Maintaining QMS documentation, adhering to company policies and cGMP regulations.
  • Promoting a culture of compliance and efficiency within the business.
  • Leading the team to achieve excellence through development and growth.

An estimated salary range for this position is £60,000 - £80,000 per annum, based on qualifications and experience.



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