Senior Quality Assurance Manager
vor 20 Stunden
We are seeking a highly experienced Senior Quality Assurance Manager to lead our QA team in ensuring the quality and compliance of our pharmaceutical operations.
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 compliance activities within the site.
- Interact with various levels of staff, customers, and auditors to determine and implement compliance processes that impact products.
- Coordinate and lead QA activities, 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.
- A Master's degree in a life science field is required; equivalent work experience and knowledge can substitute.
- A 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. We value diversity, inclusion, and collaboration.
Estimated Salary:$120,000 - $160,000 per year
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