Site Qualification Manager, Quality Assurance
Gilead
IT
2 gg fa

Job Description

Following the 2017 acquisition of Kite Pharma by Gilead Sciences, Kite will be using the established Gilead infrastructure to bring its innovative oncology therapies to France.

We are seeking highly motivated individuals to join us as Manager(s), Quality Assurance - Site Qualification in France. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.

This individual will work cross functionally to assist with the development and implementation of a qualification and monitoring program for medical apheresis and treatment centers that supports Kite’s rapid expansion of our first commercially marketed cell therapy product in the EU.

The position is part of the European Technical Operations team.

Responsibilities (include but are not limited to) :

  • Assist in management of the collection app system.
  • Assess and approve any changes to collection app, courier tracking, order intake and order processing systems to assure validated state of the systems is maintained
  • 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.
  • Perform selection audits, qualify and monitor compliance to qualification requirements.
  • 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 management of the collection system.
  • Assess and approve any changes to collection app, courier tracking, order intake and order processing systems to assure validated state of the systems is maintained
  • 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.
  • Ability to travel up to 40%
  • Perform other duties as assigned
  • Requirements :

  • Bachelor’s degree in Nursing, biological sciences, nursing, medical technologist or related field
  • Proficiency in English and local language
  • 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.

  • Experience managing external suppliers, blood banks, and plasma centers.
  • Medical center or pharmaceutical auditing experience preferred.
  • Experience in areas such as Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centers preferred.
  • Previous experience presenting and responding to regulatory agency or certification audits, preferred.
  • Proficient in MS Word, Excel, and Power Point
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Team player
  • Relevant experience working in multicultural and cross functional teams
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
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