Sr. Specialist, Quality Systems (DEV/CAPA support)

Kite Pharma
Santa Monica, CA, United States
Sep 04, 2020
Required Education
Bachelors Degree
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

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

Job Description

Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

We are seeking a highly motivated individual to join us as Sr. Specialist, Quality systems, who will provide structure, support, and metrics for the Global CAPA Board and the Global Deviation, CAPA, and EV processes. This includes guidance and support as QA Approver for Global CAPA records. The position will report to the Senior Director, Global Quality Systems and will be located at the Kite headquarters in Santa Monica, CA.

  • Provide Quality guidance and support on Global CAPA records. This includes being the QA Approver for Global CAPA records.
  • Organize the Global CAPA Board meetings by preparing agendas, meeting minutes, and follow-up on action items.
  • Perform a variety of day-to-day tactical activities to support compliance with internal processes and procedures.
  • Participate in the development, implementation, and maintenance of procedures and forms supporting Deviation, CAPA, and EV execution.
  • Complete metric reports and metric follow-up actions including the monitoring of Corporate Functions and Global Deviation, CAPA, and EV records to ensure compliance to procedure in support of weekly governance and Quarterly Management Reviews.
  • Support Global Process Owner with Deviation/CAPA/EV initiatives related to communication, metrics, and continuous improvement efforts.
  • Deliver Deviation/CAPA/EV training for Corporate Functions. Assist sites as training host, or co-host when needed.
  • Assist in the development of effective training materials for Deviation/CAPA/EV.
  • Participate in the Deviation/CAPA/EV Network activities and continuous improvement efforts
  • Work autonomously to tactically execute strategic plans

  • Bachelor's Degree in Engineering, Sciences, or related field.
  • Minimum of 7 years of progressive Quality and/or Manufacturing experience in a pharmaceutical, biotech, biologics, and/or cell therapy operations
  • Knowledge and experience in a highly regulated manufacturing environment.
  • Knowledge and experience in pharmaceutical Quality Systems, especially Deviations and CAPA
  • Understanding of aseptic manufacturing and/or cell therapy processes.
  • Knowledge and understanding of global regulatory compliance guidelines specific to Quality Systems, including Deviations and CAPA
  • Demonstrated ability to train and coach staff.
  • Excellent verbal, written, and interpersonal communication skills.

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 Sign up to follow @KitePharma on Twitter at

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For Current Kite Pharma Employees and Contractors:

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