Senior Quality Assurance Manager
Vor 5 Tagen
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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