Senior Manager of Quality Engineering
Quality Control | Santa Monica, CA | Full Time
Kite Pharma, Inc. is focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to eradicate cancer cells. We believe our immunotherapy is a market-redefining approach to the treatment of cancer. We are an innovative and growing company located in beautiful Santa Monica and have a highly energized and accomplished team. We had one of the most successful biotechnology IPOs in 2014 and have a current market capitalization of well over $2 billion (NASDAQ: KITE).
We are seeking a highly motivated individual to join us as a Senior Manager of Quality Engineering. You will work with the quality teams in supporting our efforts in this exciting new area of cancer immunotherapy. In this role you will develop and manage the Quality Engineering function in product manufacturing, analytical testing and supplier quality at Kite Pharma. Develop and manage the overall strategy for process, method, automation and facility qualification. Work closely with process development staff to improve the reliability of processes and methods through process and method development and characterization. Develop and implement efficient and reproducible quality and operations systems for clinical operations and commercial launch of our products. Develop and implement a validation system, change control, Corrective And Preventative Action (CAPA) program. Develop and implement risk management strategy and tools for Kite Pharma. You will report to the Director of Quality Control.
Responsibilities (include but are not limited to):
- Develop and implement qualification and validation system
- Risk based approach to utility, process and method characterization, qualification and validation
- Work closely with research and development to create full process and method characterization plans and studies/protocols then execute studies and write summary reports
- Develop validation master plans based on FDA/ISPE guidance for all utilities, processes and methods related to Kite products
- Write and execute validation protocols for equipment and processes
- Life cycle product validation and continuous process improvement
- Prepare and write relevant sections of IND and BLA documents
- Develop and implement Kite Pharma Risk management and statistical tools
- Develop and implement Kite Pharma risk management tools for justification of specifications and processes
- Work closely with process development and quality control to identify areas of risk and strategies to reduce or eliminate those risks
- Develop and implement Kite Pharma statistical tools for process, method and supplier monitoring.
- Sustain relevant trending and monitoring programs
- Quality System development and implementation
- Develop the change control system and work with document control to process them
- Develop and sustain a robust CAPA system
- Develop and implement product complaint management system for clinical trials and eventual commercial product launch
- Develop and implement supplier qualification system to fully qualify all component and material suppliers and assure back up suppliers are in place and resolve reliability and quality issues with suppliers
- Develop robust CMO and CRO oversight program
- 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, and critical suppliers
- Provide leadership and guidance during FDA or other board of health inspections
- Perform other duties as required
- At least 7 years in a technical role in quality engineering, manufacturing, or engineering in a biotech or pharmaceutical company with at least 2 years experience managing a team
- BS in Engineering, Chemistry or biological sciences (education or training in cell culture and gene therapy a plus)
- The ideal candidate is well versed in various quality system functions including CAPA, risk based approach to facility, equipment and process validation with reference to cell therapy products
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- Equipment and utility IQ/OQ/PQ/PV
- Strong knowledge of aseptic manufacturing and EM processes
- Strong knowledge of GMP, SOPs and quality systems processes
- Proficient in MS Word, Excel, Power Point, Visio, Project, statistical software, and other applications
- Proficient in drafting and completing highly technical documents and presentations
- Ability to work independently with outside companies to complete complex tasks
- Prior experience managing a team and growing a functional area
- 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 200 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.