Associate Director, Quality Assurance - Operations - United States
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.
Responsibilities (include but are not limited to):
- Receipt of starting materials.
- Review batch-related documentation, and ensures resolution of issues to release product.
- Oversee the product disposition process.
- Oversee the packaging and shipping process.
- Ensure all product-related Deviations are initiated, investigated and resolved. Ensures that associated CAPAs are initiated and resolved, as needed.
- Chair the Material Review Board meetings as required.
- Ensure Change Controls are initiated, evaluated and implemented appropriately for all regulated changes.
- Develop and implement Quality on the floor processes, including batch record review.
- Ensure process control measures are in place and followed in product manufacturing.
- Maintain and report monitoring and control metrics for Quality Systems in support of the Management Review.
- Schedule staff to support manufacturing and packaging processes in order to ensure on-time delivery of product to patients.
- Recruit, train, manage, and develop staff.
- 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, biotech, or biologics operation
- Minimum of 3-5 years of management/leadership experience
- Working knowledge and ability to apply GMPs 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 staff
- Excellent 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 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 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. 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.