Quality Assurance Lead

hace 4 semanas

Madrid, Madrid, España Gilead Sciences, S.L. A tiempo completo

Position Overview

The Quality Assurance Lead role is an integral part of the European Product Distribution and Quality team at Gilead Sciences, S.L.

This position 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 effective management of ATC relationships and oversee 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.


• Maintain the monitoring schedule and the approved ATC list.


• Assist in resolving issues and discrepancies related to ATC and courier operations, including conducting investigations as necessary.


• Contribute to the development, implementation, and management of the ATC management system (Oracle Agile).


• Support inspection readiness initiatives and engage with regulatory bodies during inspections related to ATC matters, as required.


• 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 nursing, apheresis/transplant/infusion centers, or blood banks; experience in pharmaceutical, vaccines, or biologics quality systems is preferred.


• Proficiency 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.


• Previous 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.


• Ability to work effectively as part of a team.


• Relevant experience in multicultural and cross-functional teams.


• Comfortable in a dynamic, fast-paced environment with minimal supervision and able to 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 hiring the most qualified individuals for positions across the company, ensuring that all employment actions are conducted without discrimination based on protected characteristics.

For Current Gilead Employees and Contractors:

Please log onto your internal portal to apply for this position.

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