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Quality Assurance Lead
hace 2 meses
Position Overview
The Quality Assurance Lead is an integral member of the European Product Distribution and Quality team.
This role involves significant travel, both nationally and internationally, potentially up to 50% of the time.
Key Responsibilities:
- Conduct selection audits and ensure adherence to qualification standards.
- Support the management of the apheresis and treatment center (ATC) qualification process utilizing risk-based methodologies for qualification, training, monitoring, and disqualification.
- Collaborate with Commercial operations for the effective management of ATC relationships and oversee the Supply Chain processes related to courier qualification and monitoring.
- Administer quality agreements with the ATC.
- Evaluate and authorize modifications to apheresis collection modules, cell order tracking, and order processing systems to maintain their validated status.
- Oversee the monitoring schedule and maintain an approved list of ATCs.
- Assist in resolving issues and discrepancies involving ATCs and couriers, including conducting investigations.
- Contribute to the development, implementation, and management of the ATC management system (Oracle Agile).
- Prepare for inspections and liaise with regulatory bodies regarding ATC-related matters as necessary.
- Perform additional duties as assigned.
Qualifications:
- Bachelor's degree in Nursing, Biological Sciences, Medical Technology, or a related field.
- Relevant experience in a medical or pharmaceutical setting, including roles in nursing, apheresis/transplant/infusion centers, or blood banks; experience in pharmaceutical, vaccines, or biologics quality systems is preferred.
- 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 Word, Excel, and PowerPoint.
- Strong interpersonal, verbal, and written communication skills are essential in this collaborative environment.
- A team player with relevant experience in multicultural and cross-functional teams.
- Ability to thrive in a fast-paced, small company environment with minimal supervision and adapt workload based on shifting priorities.
- Self-motivated, detail-oriented, and open to taking on temporary responsibilities outside of the initial job description.
Equal Employment Opportunity (EEO)
Gilead Sciences, Inc. and its subsidiaries are committed to recruiting and employing the most qualified individuals for positions across the organization. All employment actions are conducted on a non-discriminatory basis, in accordance with applicable laws.
