Quality Assurance Manager
hace 2 días
Gilead Sciences is seeking a highly skilled Quality Assurance Manager to join our European Product Distribution and Quality team. As a key member of our team, you will be responsible for ensuring the quality of our products and services, while also collaborating with our Commercial operations to manage relationships with apheresis and treatment centers (ATCs).
Key Responsibilities:- Perform selection audits, qualify, and monitor compliance to qualification requirements.
- Assist in the management of ATC qualification processes, using risk-based tools for qualification, training, monitoring, and disqualification.
- Collaborate with Commercial operations to manage ATC relationships and Supply Chain for courier qualification and monitoring processes.
- Manage quality agreements with ATCs.
- Assess and approve changes to apheresis collection modules, cell order tracking, and order processing systems to ensure validated state.
- Maintain monitoring schedules and approved ATC lists.
- Assist with resolution of ATC and courier issues and discrepancies, and investigations to resolve issues.
- Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.
- Bachelor's degree in Nursing, biological sciences, nursing, medical technologist, or related field.
- Relevant experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, or blood banks, preferred; or pharmaceutical, vaccines, or biologics quality systems roles.
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