Senior Quality Assurance Manager

vor 4 Wochen


Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Vollzeit

Job Summary:

We are seeking a highly experienced Senior Quality Assurance Manager to lead and manage a team of QA professionals, providing direction and support for their professional development. The ideal candidate will have a strong understanding of international health authority guidelines, especially Swissmedic and US FDA.

Key Responsibilities:

  • Lead and manage a team of 5-6 QA professionals, providing direction and support for their professional development.
  • Provide oversight and supervision of the compliance activities within the organization.
  • Interact with varying levels of staff within the organization as well as with customers and auditors to determine and successfully implement compliance processes that impact the product.
  • Coordinate and lead QA activities and programs such as quality agreements, metrics, auditing, record review, final product functions, complaints, document management, and oversight of quality systems and/or investigations within QA.
  • Ensure strict adherence to cGMP and the lifecycle of associated procedures.
  • Lead the implementation of inspection readiness at the site.

Requirements:

  • Master's degree in a life science field is required. Equivalent work experience and knowledge can substitute.
  • Minimum of 6 years of proven experience in quality assurance and regulatory compliance.
  • Excellent knowledge of Operations and Quality Assurance for biological pharmaceuticals (cGMP).
  • Strong understanding of international health authority guidelines, especially Swissmedic and US FDA.
  • Exceptional communication and leadership skills.

About Thermo Fisher Scientific:

We are driven by our mission to enable our customers to make the world healthier, cleaner, and safer. Our company values diversity, inclusion, and collaboration.



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