Assoc Director, Quality Assurance
Gilead
IT
8 gg fa

Job Description

Responsibilities (include but are not limited to) :

  • Release of Cell Therapy Finished Products in Canada.
  • Review of batch-related documentation to ensure GMP compliance for release of Finished Product.
  • Oversight of deviation investigations for the manufacture, packaging and shipping events in / to Canada
  • Provide QA oversight and approval of Product related deviations.
  • Provide QA oversight and approval of Change Control records impacting Cell Therapy Products in Canada.
  • Ensure Quality Systems are in place to follow Canadian GMP requirement and Marketing Authorization(s).
  • Maintain metrics related to Quality of Commercial Cell Therapy Product(s).
  • Participation in the Annual Product Report (APR) data assembling, reporting, and conclusions.
  • Responsible for updates to procedures and forms as needed.
  • Canadian Lead for potential defective product, serious deviation, or recall / Field Corrective Actions and reporting to Health Canada (HC)
  • Requirements :

  • Bachelor’s degree in the biological sciences or related field and minimum of 10 years progressive experience in a pharmaceutical, biotech, or biologics operation, or equivalent education / work experience.
  • Working knowledge and ability to apply GMPs in conformance to Health Canada and ICH standards
  • Ability to effectively negotiate and build collaboration amongst individuals
  • Good interpersonal, verbal and written communication skills
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • 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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