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.