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Quality Manager, Early Phase

Company: BioTalent
Location: Idanha
Posted on: February 23, 2021

Job Description:

We are currently recruiting for a Quality Manager to join a global biologics company working on a new state-of-the-art early phase facility.
You will be responsible for building, maintaining and sustaining a strong quality environment suitable for development, pre-clinical and clinical activities for pharmaceutical production. This role will offer you

  • Opportunity to evolve within a management position with oversite of a new early phase suite which is currently being developed
  • The challenge and opportunity of solving complex problems and developing new ideas in life sciences
  • Opportunity to work at the forefront of science
    You will be responsible for
    • Supporting the implementation and maintenance of a successful Quality System suitable for an early phase clinical setting
    • Managing, leading and training a growing team of QA
    • CAPAs, change controls, deviation management, risk assessments, root cause analysis and equipment validation
    • Internal and external audits, maintaining strong relationships with regulatory authorities
    • Ensuring R&D, product development and clinical procedures, equipment, facilities maintain a constant state of audit readiness
      You will bring the following
      • Strong experience within a QA role in a GMP working environment with regards to QMS activities
      • Early phase pharmaceuticals and NPD (New Product Development) for small molecules
      • Management/supervisory experience
      • BSc in a relevant Life Sciences subject Please apply / email me at or call to have a confidential discussion about this great opportunity.

Keywords: BioTalent, Salem , Quality Manager, Early Phase, Executive , Idanha, Oregon

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