Quality Assurance Manager

4 weeks ago


Manchester, United Kingdom Albion Rye Associates Full time

This is a key leadership role requiring a candidate with demonstrable experience in Quality, strategic thinking, exceptional communication, and analytical skills to support our clients’ vision, mission, and values.


Responsibilities:

  • Ensure compliance with all applicable standards and legislative requirements in line with EU regulations.
  • Collaborate with the global QA team to implement an Electronic Quality Management System and enhance Integrated Management Systems.
  • Oversee regulatory, customer, and vendor audits.
  • Develop and maintain initial and ongoing training programmes across all divisions of the organisation.
  • Manage the Change Control process to ensure the controlled implementation of all GxP-related changes in accordance with relevant SOPs.
  • Review and approve Corrective and Preventive Actions (CAPAs), ensuring proper tracking, follow-up, and evaluation of their effectiveness.
  • Lead and oversee QA responsibilities related to Packaging and Labelling activities, ensuring successful implementation.
  • Conduct validation and qualification of GMP equipment, systems, and facilities.
  • Maintain regular communication across all departments (QA, Logistics, Project Management, Sourcing, Purchasing, Operations, HR, Regional Teams, etc.) to ensure seamless information flow.


Skills, Experience, and Qualifications:

  • At least 3 years of QA experience within clinical trials, pharmaceuticals, or medical devices.
  • Qualified RP (Responsible Person), with prior experience as the lead RP.
  • Strong understanding of European regulations and guidelines.
  • A diploma or degree from a recognised college or university, or equivalent professional experience.
  • Supervisory experience is desirable.
  • Familiarity with Electronic Quality Management Systems.
  • Willingness and flexibility to travel as required.
  • GMP or GDP experience within pharmaceuticals, medical devices, or clinical trial supplies (CTS).



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