Associate Director, Quality Systems
Quality | El Segundo, CA | 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 an accomplished, highly motivated Quality Systems professional to join us as an Associate Director, Quality Systems. In this position the candidate will be responsible for enhancing and sustaining the management review program and other tactical metric review meetings at the commercial manufacturing site. The Associate Director, Quality Systems will report to the Director of Quality Systems and will work closely with corporate and clinical partners to create and implement workflows and business processes that align with best practices that ensure right first time.
- Author quality system trend reports and develop metric control plans for management review reporting.
- Establish meaningful thresholds for quality system metrics.
- Develop or enhance metric control plans for operational review areas including manufacturing supply management, quality system management, and product and process management.
- Discuss data trends with functional departments, learn special causes and common causes for variation.
- Teach teams how to interpret data trends and appropriate action plans for out of trend results.
- Collaborate with cross functional teams to solve problems and analyze data.
- Facilitate monthly metric review meetings at the commercial manufacturing site.
- Enhance and develop quality risk management tools and methodologies and apply to the commercial quality system.
- Facilitate and or lead execution of risk management activities at the commercial site.
- Facilitate and lead complex investigations, utilize structured approach to root cause analysis and corrective action plan development.
- Led development of the annual product quality review templates, data analysis and report creation.
- Compile data, analyze data, draw data driven conclusions and develop risk based action plans through the CAPA system for management review outputs and annual product quality reviews.
- Perform other duties as required.
- Bachelor’s Degree in Engineering, Chemistry or biological sciences or equivalent.
- 12 years in a technical role in technical operations, quality engineering, validation, quality assurance or quality systems.
- Able to work effectively with autonomy
- High degree of quality data management: trend analysis, interpretation, and application.
- Must be numerically inclined, adept at data computation, trending, especially Statistical Process Control techniques
- Must be mechanically inclined, enough to understand and articulate equipment, utility, and facility operation
- Must effectively interact, communicate and work across the organization with each and every job function from senior management to staff
- Must facilitate cross-functional discussions in an objective and neutral fashion
- Strong knowledge of GMP, SOPs and quality system processes and statistical analysis.
- Proficient in MS Word, Excel, Power Point, Visio, Project, statistical software, and other applications.
- Experience in pharmaceutical or bio-pharmaceutical field.
- Education or training in cell culture and gene therapy a plus.
- Proficient in drafting and completing highly technical documents and presentations.
- Quality systems demonstrated knowledge in areas such as quality risk management and management review.
- Working knowledge of quality systems and FDA and EU regulatory requirements.
- While most of the schedule will be during a standard work-week, there will be occasional weekend work required.
- Must be able to travel <10%.
Kite Pharma, is headquartered in Santa Monica, CA. 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.