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