Manager, QA Systems & Compliance

at  Thermo Fisher Scientific

MANAGER, QA SYSTEMS & COMPLIANCE

Thermo Fisher Scientific Inc. Lengnau is seeking an exceptionally qualified individual with a strong track record and experience in managing QA Systems & Compliance to join our team as the Manager of QA Systems & Compliance. In this role, you will have the unique opportunity to lead the implementation and maintenance of our world-class quality assurance systems, ensuring flawless compliance with regulatory requirements.

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.
  At Thermo Fisher Scientific, we are driven by our mission to enable our customers to make the world healthier, cleaner, and safer. Join our team and be part of a company that values diversity, inclusion, and collaboration.

• 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 Lengnau site.
• 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.