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Senior Qualified Person (QP) Manager

AssureBio
Birmingham
4 weeks ago
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Are you a proven leader in pharmaceutical Quality Assurance with a strong background in QP oversight and team development?


Do you have the vision and drive to lead Qualified Person operations across multiple sites, shaping strategic quality direction while mentoring high-performing teams?


We are recruiting for aSenior QP Managerto take on a pivotal leadership role within a dynamic and highly regulated radiopharmaceutical manufacturing environment.


This position offers the opportunity to lead a team of Qualified Persons, influence quality strategy at a national level, and ensure excellence in GMP compliance across UK operations.


About the Role


As a Lead QP, you will play a critical role in ensuring the safe release of radiopharmaceutical products across multiple sites in the UK. You will be responsible for:


  • Managing and leading a team of permanent and contract Qualified Persons (QPs) across multiple UK manufacturing sites.
  • Acting as a Releasing QP for radiopharmaceuticals/sterile products under a UK MHRA licence.
  • Chairing the QP Forum and contributing to site Quality Management Meetings.
  • Ensuring compliance with GMP, UK/EU regulations, and local/global procedures.
  • Reviewing and certifying batches in a timely manner while overseeing deviations, complaints, CAPAs, and OOS/OOT investigations.
  • Supporting MHRA inspections at key manufacturing sites.
  • Acting as a mentor and coach for quality teams, fostering a culture of compliance and continuous improvement.
  • Working closely with the Head of Quality to enhance and maintain the Global Quality System.


Experience & Qualifications


  • Eligible to be named as a Qualified Person (QP) on a manufacturing licence.
  • 10+ years’ Quality Assurance experience within a UK-licensed pharmaceutical organisation.
  • 5+ years’ experience managing Quality teams in Quality Assurance or Quality Control.
  • Previous experience in QP certification of medicinal products.
  • Background in pharmaceutical manufacturing, preferably in sterile or radiopharmaceutical production

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National AI Awards 2025

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