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 necessitates the capacity to travel both nationally and internationally, with travel expectations of up to 50%.
Key Responsibilities (including but not limited to):
• Conduct selection audits, ensuring compliance with 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 to manage ATC relationships and oversee Supply Chain processes for courier qualification and monitoring.
• Oversee quality agreements with the ATC.
• Evaluate and authorize any 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 roster.
• Assist in resolving ATC and courier discrepancies and conduct investigations to address these issues.
• 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 concerning ATC-related 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; OR roles in pharmaceutical, vaccines, or biologics quality systems.
• 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 MS Word, Excel, and PowerPoint.
• Exceptional interpersonal, verbal, and written communication skills are crucial in this collaborative environment.
• A team-oriented mindset.
• Relevant experience working within 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 throughout the company. All employment actions are conducted on a non-discriminatory basis, without regard to protected characteristics or prohibited grounds, in accordance with applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your internal portal to apply for this position.
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