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Affiliate Quality & Compliance Manager

Azza HealthCare Agency
Onsite / United KingdomFull timeLead / Manager
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About the role

Role:

The UK Affiliate Quality Director leads the establishment and management of the affiliate Quality Management System, ensuring compliance with UK GDP, MHRA requirements, and global standards. They serve as the Responsible Person (RP & RPi) for the Wholesale Distribution Authorization (WDA(H)) and oversee quality operations without line management duties.

Key Responsibilities

  • Lead quality activities for affiliate setup, launch readiness, and ongoing operations.
  • Develop and maintain QMS, procedures, training, and supply-chain controls.
  • Provide independent quality advice to leadership and escalate compliance risks.
  • Ensure regulatory compliance, act as primary contact for inspections, and exercise authority over product quality, including product holds and distribution suspensions.
  • Manage deviations, CAPAs, change controls, and oversee GxP service providers.
  • Handle distribution quality issues, product recalls, and ensure traceability and safety features.

Qualifications & Skills

  • Degree in pharmacy, pharmaceutical sciences, or related field.
  • 10+ years of pharmaceutical Quality experience with strong GDP expertise in the UK.
  • Knowledge of UK GDP, MHRA WDA(H) requirements, and pharmaceutical importation processes.
  • Experience as an RP/RPi, with demonstrated ability to provide independent quality oversight in a global matrix environment.

Reporting & Location:

Reports to the Senior Director of Global Affiliates Quality, works closely with the UK General Manager, and is based in London, with travel as needed.

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