Quality Assurance Manager
hace 1 mes
The Quality Assurance Manager will be part of the European Product Distribution and Quality team, responsible for ensuring compliance with qualification requirements and managing quality agreements with external suppliers. The role requires travel nationally and internationally up to 50% and involves collaborating with Commercial operations and regulatory agencies.
Key Responsibilities- Perform selection audits and qualify and monitor compliance to qualification requirements.
- Assist in the management of an apheresis and treatment center (ATC) qualification process using risk-based tools.
- Collaborate with Commercial operations in the routine management of ATC relationships and Supply Chain for courier qualification and monitoring processes.
- Manage quality agreements with the ATC.
- Assess and approve changes to apheresis collection module, cell order tracking, and order processing systems.
- Maintain the monitoring schedule and approved ATC list.
- Assist with resolution of ATC and courier issues and discrepancies.
- Support inspection readiness plans and interact with regulatory agencies during inspections.
- Bachelor's degree in Nursing, biological sciences, medical technologist, or related field.
- Relevant experience in a medical or pharmaceutical environment, including nursing, apheresis / transplant / infusion centers, or blood banks.
- Proficiency in English, Spanish, and recommended Portuguese.
- Experience managing external suppliers, blood banks, and plasma centers.
- Medical center or pharmaceutical auditing experience preferred.
- Experience in areas such as Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centers preferred.
- Previous experience in Quality Assurance, preferred.
- Proficient in MS Word, Excel, and Power Point.
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