Job Description
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer, working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination, and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions,
and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed, and empowered to fulfill their aspirations. Join Gilead and help create possible, together.
Job Description: The position is part of the European Product Distribution and Quality team. The role requires the ability to travel nationally and internationally up to 50%.
Responsibilities (include but are not limited to):
Perform selection audits, qualify and monitor compliance to qualification requirements.
Assist in the management of an apheresis and treatment center (ATC) qualification process that will use risk-based tools for qualification, training, monitoring, and disqualification.
Collaborate with our Commercial operations in the routine management of the ATC relationships and Supply Chain for courier qualification and monitoring processes.
Manage quality agreements with the ATC.
Assess and approve any changes to apheresis collection module, cell order tracking, and order processing systems to assure validated state of the systems is maintained.
Maintain the monitoring schedule and approved ATC list.
Assist with resolution of ATC and courier issues and discrepancies, and the investigations to resolve the issues.
Assist in development, implementation, and management of ATC management system (Oracle Agile).
Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.
Perform other duties as assigned.
Requirements: Bachelor's degree in Nursing, biological sciences, nursing, medical technologist or related field.
Relevant experience in a medical or pharmaceutical environment, including nursing, apheresis / transplant / infusion centers, or blood banks, preferred; OR pharmaceutical, vaccines or biologics quality systems' roles.
Proficiency in English, Spanish and recommended Portuguese.
Experience managing external suppliers, blood banks, and plasma centers.
Medical center or pharmaceutical auditing experience preferred.
#J-18808-Ljbffr
