Associate Director, Quality Operations
Quality | Santa Monica, CA | Full Time
Kite Pharma is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team. Kite is publicly traded (NASDAQ: KITE) with a current market well over $2 Billion.
We are seeking a highly motivated individual to join us as an Associate Director, Quality Operations. In this position, you will direct the activities of the plant Quality Assurance department and coordinate the total plant quality assurance effort to ensure conformance to Kite Pharma quality standards and government regulations. The candidate will provide objective evaluation of process performance and product quality and develop staff for continual contributions towards plant quality goals.
Responsibilities (include but are not limited to):
- Reviews batch-related documentation, and ensures resolution of issues to release product.
- Oversees the product and raw material disposition process.
- Ensures all product-related Deviations and CAPAs are initiated, investigated and resolved, as needed.
- Chairs the Material Review Board meetings to ensure non-conforming material is appropriately dispositioned.
- Ensures change controls are initiated, evaluated and implemented appropriately for all regulated changes.
- Develops and implements Quality on the floor process.
- Ensures process control measures are in place and followed in product manufacturing.
- Maintains and conducts internal site audits.
- Maintain and reports monitoring and control metrics for process performance and product quality.
- Bachelor’s degree in the biological sciences or related field; Master’s degree preferred
- Minimum of 10 years’ progressive quality or manufacturing experience in a pharmaceutical or biologics operation; biologics or vaccines experience preferred
- Minimum of 3-5 years of management/leadership experience
- Working knowledge and ability to apply GMP in conformance to U.S., EU, and ROW standards
- Ability to effectively negotiate and build collaboration amongst individuals
- Demonstrated ability to develop, coach, and mentor key employees
- 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
Kite Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Blvd and right off the 10. We are able to offer the opportunity to be part of the first 500 employees in this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation. Did we forget to mention the stock options? To learn more about us, please visit our website at www.kitepharma.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
No phone calls please and no agencies or recruiters.