Director, Quality Assurance
Quality | Santa Monica, CA | Full Time
Kite Pharma Inc, founded in 2009, is dedicated to the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to fight tumor cells. We are a small, dynamic and accomplished team with an exciting growth trajectory for the coming year.
We are seeking a highly motivated individual for the role of Director, Quality Assurance to work in this exciting new area of cancer immunotherapy. You will develop and manage the Quality Assurance function in product development, manufacturing, analytical testing, and product release and supplier quality at Kite Pharma. Additionally, you will develop and manage the overall quality strategy including the quality systems for both GMP and GCP functional areas. 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.
Responsibilities (include but limited to):
- Develop and implement quality systems for the clinical research, product development and commercial launch functions by utilizing a quality manual to guide the development of the quality system, systematically developing and implementing each quality system as required by the business and developing policies and procedures based on business need and also current best industry risk based practices
- Manage lot release system utilizing CMOs, outside testing laboratories and product logistics teams
- Assure all product quality issues are identified and resolved prior to product release
- Assure rigorous oversight of all contract and internal operations through well developed communication channels
- Assure each site is compliant with all deviation, change control and supplier change procedures
- Manage the auditing function for Kite Pharma by developing and managing detailed audit plans for all contract CROs, CMOs, outside testing laboratories, and internal Kite operations
- Develop and implement supplier qualification system to fully qualify all component and material suppliers
- 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
- Other duties as assigned
- 10 or more years experience in a technical role in quality assurance, manufacturing, analytical testing or engineering with at least 5 years in a related management role
- BS in Engineering, Chemistry, Biological Sciences or related field with an education or training in cell culture and gene therapy a plus
- Experience in medical device or pharmaceutical bio-pharmaceutical field preferred
- ASQ Auditor certification, ASQ Quality Engineer certification preferred
- Proficient in MS Word, Excel, Power Point, Visio, Project, statistical software, and other applications
- Proficient in drafting and completing highly technical documents and presentations
- Document management systems demonstrated knowledge in areas such as technical document creation, electronic and paper archival and retrieval
- Ability to work independently with outside companies to complete complex tasks
- 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 Boulevard and right off the 10 Freeway. We are able to offer the upside of working in a small, but growing company where everyone knows your name and respects your opinion while at the same time offering top-notch benefits. 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.