Quality Assurance Manager

hace 1 mes


Madrid, Madrid, España Gilead Sciences, Inc. A tiempo completo
Job Description

The European Product Distribution and Quality team is seeking a Quality Assurance Manager to join their team. The successful candidate will be responsible for performing selection audits, qualifying and monitoring compliance to qualification requirements.

Responsibilities
  • Perform selection audits, qualify and monitor compliance to qualification requirements.
  • Assist in the management of an apheresis and treatment center (ATC) qualification process that will use risk-based tools for qualification, training, monitoring, and disqualification.
  • Collaborate with our Commercial operations in the routine management of the ATC relationships and Supply Chain for courier qualification and monitoring processes.
  • Manage quality agreements with the ATC.
  • Assess and approve any changes to apheresis collection module, cell order tracking, and order processing systems to assure validated state of the systems is maintained.
  • Maintain the monitoring schedule and approved ATC list.
  • Assist with resolution of ATC and courier issues and discrepancies, and the investigations to resolve the issues.
  • Assist in development, implementation, and management of ATC management system (Oracle Agile).
  • Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.

Requirements
  • 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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