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Gilead

Sr Manager, Quality Assurance (Bilingual)

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

We are seeking a highly motivated bilingual (English and French) individual to join us as a Senior Manager, Quality Assurance - Site Qualification in Canada.  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 our rapid expansion of our first commercially marketed cell therapy product in Canada.  This position can be remotely located, and will report to the Director, Quality Assurance, Site Qualification, at Gilead Sciences Canada Inc., in Mississauga, Ontario, Canada.

Responsibilities (include but are not limited to):

  • 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 team in the routine management of the ATC relationships and Supply Chain for courier qualification and monitoring processes.
  • Perform selection audits, and qualify and monitor compliance to qualification requirements.
  • Assist with resolution of ATC and courier issues and discrepancies, and the Quality records investigations to resolve the issues.
  • Assist in creation and management of the apheresis collection process for patient traceability and apheresis material handling.
  • Support SOP and associated document development and revision, as indicated.
  • Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.
  • Ability to travel up to 40%, could include some weekend travel for arrival to/return from destinations, and up to 60% during launch preparation

Requirements:

  • Verbal and written proficiency in English and French is mandatory
  • Bachelor’s degree in Nursing, biological sciences, nursing, medical technologist or related field
  • 8+ years of progressive 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, or 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
  • 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.


Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
 

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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