Senior Specialist, Quality Assurance - Site Qualifications
Quality | Santa Monica, CA | Full Time
Kite Pharma, Inc., 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 Senior Specialist, Quality Assurance – Site Qualifications. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy. This individual will work cross functionally to assist with the development and implementation of a monitoring program for apheresis center and treatment sites (ATC) that supports Kite’s rapid expansion to commercial manufacturing and first marketed product. This role will be a hands-on resource reporting to the Director, QA Site Qualifications.
- Assist in the development and management of the site qualifications monitoring and oversight process of authorized hospitals.
- Assist in the development, implementation and management of an electronic system to maintain and track site qualification activities in a validated state.
- Assist in change, development and management of the Apheresis Collection Application System.
- Assist with resolution of ATC issues and discrepancies, and the investigations to resolve the issues.
- Assist with document change requests, change control, deviation and CAPA systems.
- Collaborate with cross-functional departments to ensure timely implementation of quality records.
- Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.
- Perform other duties as assigned
- Bachelor’s degree in biological sciences, nursing, medical technology or related field.
- Minimum of 5 years progressive experience in pharmaceutical or biologics quality systems’ roles; cell therapy, biologics, blood/human tissue or vaccines experience preferred.
- Experience with quality management systems, and information system development and implementation.
- Cellular & Gene Therapy Products or Blood and Blood Product experience preferred
- Strong working knowledge of and ability to apply GMP in conformance to US, EU and ROW standards.
- Previous experience presenting and responding to regulatory agency audits, preferred.
- Proficient in MS Word, Excel, and Power Point
- 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
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
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.