Associate Director of Quality Assurance, Quality Systems
Quality | 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).
Kite is seeking a highly motivated to work on innovative T cell therapy for cancer treatment. The Senior Quality Assurance Manager, Quality Systems will implement and manage Kite Pharma Quality Systems. You will also ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Kite quality practices. Additionally in this role you will manage quality assessments of internal operations, CMOs, and suppliers to analyze compliance and assess risk. You will report to the Director of QA.
Responsibilities include, but are not limited to:
- Implement, manage, audit and maintain Kite Pharma Quality Systems
- Ensure Quality Systems conformance to regulations and quality policies
- Manage Change Control system and ensure proper maintenance and approval of cGMP documents
- Manage the CAPA system and ensure timely closure and effectiveness of investigations and corrective and preventive actions
- Conduct effective root cause analysis and implement corrective action and preventative action
- Supports quality assessments of internal operations and suppliers to analyze compliance and assess risk
- Support regulatory inspections and audits
- Establish and manage supplier quality
- Coordinate and perform vendor qualification and compliance audits
- Review technical/ investigation reports as appropriate
- Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
- Provide QA guidance to product development projects and technical transfer activities
- Track, review and report metric information for use in continuous improvement of areas of responsibility
- Other duties as assigned
- Bachelor’s degree in technical discipline (Chemistry/Microbiology/Engineering or similar) or related discipline
- At least 8 years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) strongly preferred in the medical and/or pharmaceutical industry
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, ICH 10)
- At least 3 years experience managing a team
- Experience with Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles
- Strong knowledge of GMP, SOPs and quality systems
- Identifying, writing evaluating and closing CAPAs and experience with internal and external audit principals
- Strong knowledge of aseptic manufacturing processes
- Strong knowledge of change control practices/strategies
- Equipment and utility IQ/OQ/PQ/PV
- Proficient in MS Word, Excel, Power Point and other applications
- ASQ, Black Belt/Green Belt certifications preferred
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- 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.