Program Manager, Quality
Quality | Santa Monica, CA | Full Time
Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is 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. For more information on Kite, please visit www.kitepharma.com.
We are seeking a highly motivated individual to join us as Program Manager, Quality Assurance, located at our Santa Monica, California location. You will work with the Quality leadership, Technical Operations, Clinical Research, Product Development and Commercial teams in supporting our efforts in this exciting new area of cancer immunotherapy. This individual will work cross functionally in support of the overall quality function initiatives within Technical Operations. This position will report directly to the Kite quality head and operate in a matrix organizational role.
Responsible for program management of the quality function:
- Provide structure and organization for the quality leadership team using standard Kite program management tools. Assure all quality functions use the same Kite project management tools.
- Provide program management oversight for the execution of annual Global Quality Goals. This includes oversight and tracking of annual quality goals and projects from Kite corporate project management groups.
- Manage, track and follow up on all quality leadership initiatives. This includes Quality leadership development, site and corporate initiatives, tasks.
- Project manage department projects, prioritization, and timelines.
- Manage department budgets including forecasts, headcount and resource projections, outside testing lab forecasts, and contract/consultant resources. Track all contractor and consultants for budget and billing along with completion of assignments.
- Organize the quality leadership team departmental meetings, actions, presentations and project plans. Prepare departmental and companywide quality department communications.
- Assist in the inspection process including FDA, EMA and corporate audits. Assist in the internal audit process including organizing, scheduling, training and follow up.
- Ability to travel up to 20%
- Perform other duties as assigned
- Bachelor’s degree in a science field with minimum of 7 years’ experience in a program management role. Advanced business degree and project management certifications are desirable
- Experience in a pharmaceutical setting
- Experience in computer systems and risk management processes a plus
- Experience with direct US and international health authority inspections a plus
- Proficient in MS Word, Excel, Project and Power Point
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
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.