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Quality Assurance Manager
hace 2 meses
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 and compliance of our products and services.
Key Responsibilities- Selection Audits and Compliance Management: Perform selection audits, qualify, and monitor compliance to qualification requirements.
- ATC Qualification and Management: 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.
- Commercial Operations Collaboration: Collaborate with our Commercial operations in the routine management of the ATC relationships and Supply Chain for courier qualification and monitoring processes.
- Quality Agreements: Manage quality agreements with the ATC.
- System Validation and Maintenance: 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.
- Monitoring Schedule and ATC List Management: Maintain the monitoring schedule and approved ATC list.
- Issue Resolution and Investigations: Assist with resolution of ATC and courier issues and discrepancies, and the investigations to resolve the issues.
- ATC Management System Development and Implementation: Assist in development, implementation, and management of ATC management system (Oracle Agile).
- Regulatory Compliance and Inspection Readiness: Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.
- Education: Bachelor's degree in Nursing, biological sciences, nursing, medical technologist or related field.
- Experience: 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.
- Language Skills: Proficiency in English, Spanish and recommended Portuguese.
- External Supplier Management: Experience managing external suppliers, blood banks, and plasma centers.
- Medical Center or Pharmaceutical Auditing Experience: Medical center or pharmaceutical auditing experience preferred.
