Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.
Kite is seeking a highly motivated individual to join us as a Sr. Specialist, Quality Systems in our clinical cell therapy production center located in Santa Monica, CA. The Sr Specialist will be responsible for providing support of clinical manufacturing. In this role you will be responsible for technical oversight of Quality Systems and programs for cell therapy products. You will report to the Associate Director Quality Systems and Compliance.
Responsibilities (include but are not limited to):
- Be an advocate on the new Phase Appropriate Quality Systems approach of manufacturing at the clinical site
- Attend Global meetings and represent the site’s Quality Systems and Compliance team
- Develop, revise and review SOPs, qualification/validation protocols and reports.
- Monitor the GMP systems currently in place to ensure compliance with documented policies.
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
- Gather metric information for use in continuous improvement of areas of responsibility
- Investigate and manage deviations related to quality systems. Determine corrective/preventative actions (CAPA) and drive implementation.
- Participate in Inspections of the site
- Own the training program and support the site’s training needs
- Provide ILT trainings on topics as needed
- Perform document control activities including issuance and verification of manufacturing lots
- Perform all activities around scanning and archiving documents for the site
- Generate data reports on required to be presented at Tier 4 and 5 meetings and at QMRs
- Assist in the management of Quality Systems activities and provide technical direction as needed
- Perform other duties as assigned
Master’s Degree and 4+ years of Quality experience
Bachelor’s Degree and 6+ years of Quality experience
High School Degree and 10+ years of Quality experience
- Familiarity with analyzing and reporting results using graphical presentation.
- The ability to gown for entry into Aseptic core and supporting areas.
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
- Strong knowledge of GMP, SOPs and quality control processes.
- Strong data integrity knowledge and practices.
- Experience identifying, writing, evaluating, and closing OOS’s and investigations.
- Proficiency in MS Word, Excel, Power Point and other applications
- Excellent interpersonal, verbal and written communication skills
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
To discover more about Kite please visit our Career Site at https://www.kitepharma.com/careers/careers-at-kite