Manager, Quality Engineering - Computer Systems Validation
Quality | Santa Monica, CA | Full Time
Kite Pharma is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team. Kite is publicly traded (NASDAQ: KITE) with a current market well over $2 Billion.
We are seeking a highly motivated individual to manage and implement the Enterprise CSV plan under Quality Engineering to achieve and maintain compliance requirements for enterprise, manufacturing, and analytical GxP computerized systems at Kite Pharma. This role will support clinical and commercial manufacturing. The Manager, Quality Engineering - CSV will work closely with users and IT to improve the reliability of computerized systems using a systematic and risk-based approach as defined in GAMP®. Implement and maintain the overall computerized system life cycle from concept/planning, project, operation through retirement. Work closely with users and SMEs to create and implement workflows and business processes that align with best practices that ensure right first time.
- Implement and maintain the Computerized System Life Cycle (CSLC) at Kite.
- Apply risk-based principles at all stages of the CSLC.
- Work closely with users and IT to identify business and quality requirements, perform risk assessments and
- Be capable of writing test scripts, creating CSV protocols followed by assisting in executing studies and writing summary reports.
- Prepare and write relevant sections of IND and BLA documents as they pertain to computerized systems.
- Implement and maintain the Kite Pharma Enterprise Validation Master Plan.
- Work closely with users and IT to map processes, identify areas of risk (e.g. data integrity, chain of identity/custody) and strategies to reduce or eliminate those risks.
- Effectively categorize systems for the purposes of identifying CSV deliverables.
- Develop and implement a periodic system review.
- Implement and maintain the enterprise change control system.
- Work with consultants and contractors (as needed) to maintain the enterprise and site CSV.
- 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.
- At least 5 years in a technical role in enterprise system management, quality engineering, manufacturing, analytical testing or engineering.
- Bachelor of Science in Computer Science or Engineering, Chemistry or Biological sciences.
- Education or training in cell culture and gene therapy a plus.
- Experience in medical device or pharmaceutical bio-pharmaceutical field highly 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 communicate and work independently with scientific/technical personnel.
- Ability to work independently with outside companies to complete complex tasks.
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. 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.