Reference
QAGMPATMPOX
Type
Permanent
Location
Oxford
Salary
£90,000 - £110,000/annum
Category
Operations
Sector
Pharmaceuticals / Biotechnology / FMCG

ABOUT THIS ROLE

Northreach has partnered with one of the most exiting T-cell Cancer therapy company.

The organisation is moving in Clinical trials and we are looking for a QA Director with experience in setting up the QMS and promote a Quality culture at all the levels.

In this role you will be responsible to design and develop a fully compliant GXP Quality Systems (QMS) to support the transition from R&D to Clinical Manufacturing ph1/2 of ATMP products.

KEY RESPONSIBILITIES

  • Setting up a quality system from scratch to meet GxP requirements for CGT products
  • Implementing a Quality Mindset and Culture across the entire organisation
  • Writing SOP’s and other relevant GxP documents
  • Selecting an appropriate QMS, DMS, LMS solutions including tools to manage complaints, CAPA’s, Deviations, change controls and specifications
  • Identifying and qualifying external collaborators
  • Leading inspections and audits from external parties
  • Assuring appropriate oversight of external (GxP) activities, including vendor qualification, contributing on Quality Agreements, performing audits and tracking CAPA follow-ups.
  • Responsible for oversight of External CMOs and partners to assure on-time, compliant documentation and batch release.
  • Be the lead and Quality representation during any GxP audits/inspections by health authorities.

THE IDEAL CANDIDATE

  • Record in setting up Quality Management systems for large molecular products is a must.
  • Excellent interpersonal, communication, and presentation skills.
  • Cell Therapy experience, Biotech or Biopharma experience
  • Strong knowledge of biopharma industry. Familiarity/experience with end to end CMC drug development and clinical Manufacturing.
  • Degree in Life Sciences or related discipline.
  • Advanced degree in Life Sciences-related discipline strongly preferred.
  • Certification / Eligibility as EU QP and qualified GxP auditor required.
  • Ability to work cross-functionally, with matrixed teams; maintaining strong business partner relationships.
  • Strong leadership skills and executive presence; ability to positively influence outcomes.
  • Expertise in conflict resolution.
  • Excellent critical thinking and problem-solving skills.
  • Willingness to do what needs to be done in a dynamic environment.
  • Experience working in global setting.
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