Quality Assurance Lead
hace 4 semanas
Position Overview
The Quality Assurance Lead is an integral member of the European Product Distribution and Quality team, responsible for ensuring compliance and excellence in quality management.
Key Responsibilities:
- Conduct selection audits and monitor adherence to qualification standards.
- Support the management of the apheresis and treatment center qualification process utilizing risk-based assessment tools.
- Collaborate with Commercial operations for effective management of ATC relationships and supply chain processes.
- Oversee quality agreements with apheresis treatment centers.
- Evaluate and authorize modifications to systems related to apheresis collection and order processing to maintain validated status.
- Maintain the schedule for monitoring and the approved list of ATCs.
- Assist in resolving issues related to ATCs and couriers, including conducting investigations.
- Contribute to the development and management of the ATC management system (Oracle Agile).
- Prepare for inspections and liaise with regulatory bodies regarding ATC-related matters.
- Perform additional duties as assigned.
Qualifications:
- Bachelor's degree in Nursing, Biological Sciences, Medical Technology, or a related field.
- Experience in a medical or pharmaceutical setting, preferably in nursing, apheresis, transplant, infusion centers, or blood banks.
- Fluency in English, Spanish, and preferably Portuguese.
- Experience managing external suppliers, blood banks, and plasma centers.
- Preferred experience in medical center or pharmaceutical auditing.
- Background in Clinical Research, Medical Liaison, Apheresis, and Cell Therapy Medical Centers is advantageous.
- Prior experience in Quality Assurance is preferred.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
- Strong interpersonal, verbal, and written communication skills are essential for collaboration.
- A team-oriented mindset with experience in multicultural and cross-functional teams.
- Ability to thrive in a dynamic, fast-paced environment with minimal supervision and adapt to changing priorities.
- Self-motivated, detail-oriented, and open to taking on additional responsibilities as needed.
Equal Employment Opportunity (EEO)
Gilead Sciences, Inc. is committed to hiring the most qualified individuals for all positions without discrimination based on any protected characteristics.
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