Senior Quality Assurance Manager

Vor 2 Tagen


Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Vollzeit

Job Summary:

We are seeking a highly experienced Quality Assurance Manager to lead our QA team and ensure compliance with cGMP regulations.

Key Responsibilities:

  • Lead and manage a team of QA professionals, providing direction and support for their professional development.
  • Provide oversight and supervision of compliance activities within the site.
  • Interact with staff, customers, and auditors to determine and implement compliance processes.
  • Coordinate and lead QA activities, including quality agreements, metrics, auditing, and record review.
  • Ensure strict adherence to cGMP and associated procedures.
  • Lead the implementation of inspection readiness at the site.

Requirements:

  • Master's degree in a life science field or equivalent work experience and knowledge.
  • 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 a company driven by our mission to enable our customers to make the world healthier, cleaner, and safer. We value diversity, inclusion, and collaboration.



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