Director, Quality - Qualified Person
Quality | Amsterdam, Netherlands | Full Time
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.
We are seeking a highly motivated individual for the role of Director, Quality – Qualified Person to work in this exciting new area of cancer immunotherapy.
Develop and manage the Quality function for our emerging European operations. The qualified applicant will work with our product development, manufacturing, analytical testing, product release, clinical operations and supplier quality at Kite Pharma in the United States and EU. Additionally, the qualified applicant will work closely with the Kite regulatory affairs team and European health authorities to develop and manage the overall approach and strategies necessary for successful clinical trial and commercial cell therapy product launch. The role includes support for the corporate roles from the United States including the quality systems for both GMP and GCP functional areas for product specifications, raw material and component specifications. Work closely with clinical research and product development staff and our CMO’s/CRO’s to assure full compliance with regulations and internal procedures. Utilize modern quality tools such as audit, FMEA, Root Cause Analysis and other risk based tools to continually improve operations. Develop and implement efficient and reproducible quality and operations systems for clinical operations and commercial launch of our products.
1. Quality System- Develop and implement quality systems for the clinical research, product development and commercial launch functions.
- Work closely with our current Dutch CMO to assure clinical trial and commercial product launch systems are developed and implemented effectively and efficiently.
- Work closely with our United States production and testing facilities to assure compliance with EU requirements.
- Assure specifications are developed for EU and rest of world as appropriate. Systematically develop and implement specification system as required by the business.
- Develop policies and procedures based on business need and also current best industry risk based practices.
2. Qualified Person – Develop QP certification system to assure Kite Pharma meets all EU requirements and regulations.
- Develop and manage QP Lot certification system for cell therapy products produced in our Dutch CMO and also our United States facility.
- Filing documents meet EU boards of health requirements.
3. Audit, inspection and due diligence support
- Provide technical response and expertise (written and verbal) during audits, inspections and due diligence on Kite Pharma quality related topics and systems.
- Provide independent audit support for CMOs, CROs, clinical sites and critical suppliers.
- Prepare for and Lead EU boards of health inspections.
1. Qualified Person Certified within the EU and preferably certified and living within The Netherlands.
2. Proficient in drafting and completing highly technical documents and presentations.
3. Document management systems demonstrated knowledge in areas such as technical document creation, electronic and paper archival and retrieval.
4. Ability to communicate and work independently with medical, scientific/technical personnel.
5. Ability to work independently with outside companies to complete complex tasks.
6. Fluent in written and spoken English.
1. Required: At least 10 years as a QP within the EU. Management experience in leading teams within a regulatory or industry setting. Experience with EU board of health inspections.
2. Education: Minimum BS in Biochemistry, Chemistry or biological sciences. Education or training in cell culture and gene therapy a plus.
3. Preferred: Experience in cell and gene therapy processes, analytical methods and/or clinical trial processes.
Kite Pharma, an equal opportunity employer, is located in Amsterdam, Netherlands with global headquarters in Santa Monica, California. 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.