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Quality Assurance Manager

Ref: JN-032021-52929

Publié le 30 April 2021
Sciences de la vie

Modis is looking, on behalf of a client, for an expert in quality. 

Your tasks:

  • Manage, lead and coach the Quality Assurance System team.
  • Ensure conformity and application of the Quality Management Systems across the facility.
  • Manage customer audits and regulatory inspections.
  • Drive strategies to continuously improve Quality Management Systems that enable to efficiently meet customer and regulatory requirements.
  • Collaborate actively with the business partners to develop quality mindset.
  • Monitor the foreseen regulatory evolutions to anticipate new requirements and get set for the future.

Your Skills:

  • Educational background in Biology, Pharmaceutical or related domain (BSc/MSc or equivalent education in Science).
  • At least 5 years of experience in Quality Assurance in an In Vitro Diagnostics company or other related industry (Pharmaceutical, Biotechnology, Medical); including 3 years in a management role.
  • Thorough understanding of ISO Norm 13485, the European Directive 98/79/CE and IVDR and the 21CFR820.
  • Strong leadership, people management and coaching skills.
  • Excellent team player with a strong ability to communicate within a multicultural environment, at all organizational levels, and with regulatory representatives
  • Strong problem solving skills, with creative and strategic thinking.
  • Experience with project management, experience in Lean or Six Sigma projects preferred. Certification Lean / 6 or Green Belt would be a plus.
  • Either French or German as a native language. Good knowledge of the other language is a plus. English on a professional level.