Quality Systems Manager
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 a Quality Systems Manager reporting to the Corporate Compliance Quality Systems Director. Provide oversight to Kite’s corporate Change Control by ensuring changes are developed, documented, authorized, implemented and monitored in compliance with all applicable procedures. Consider appropriate assessment of regulatory and quality risks posed by proposed changes. Ensure accuracy and completeness of change records and supporting documentation and procedures. Interface and build strong partnerships with Supplier Quality Management, Global Clinical Quality, Training and other parts of Kite’s Quality organization. Manage effectively Corporate deviations, CAPAs and Effectiveness Monitoring systems.
- Establish and facilitate Corporate Change Control review board (CCCRB) in compliance with regulatory, quality, and Kite requirements.
- Ensure individual change records are developed and documented in accordance with Kite’s governing procedure.
- Collaborate with Regulatory Affairs and Product Sciences to determine the regulatory/product/process impact assessment of corporate changes.
- Oversee corporate deviations, CAPAs and EV in compliance with regulatory, quality, and Kite requirements and ensure the development of effective corrective action plans.
- Provide guidance and advice on methods, procedures, standardization and requirements associated with the change control, deviation, CAPA and EV systems.
- Collaborate with cross-functional departments to ensure timely implementation of quality records.
- Support audits (internal, external) to verify regulatory and quality requirements have been met.
- Develop and execute strategic initiatives for continuous improvement of change control, deviation, CAPA and EV systems.
- Develop, implement and deliver training content for change control, deviation, CAPA and EV processes and procedures.
- Track key performance indicators for the change control, deviation, CAPA and EV systems and reports metrics
- Responsible for policy/procedure reviews and facilitating updates for the change control, deviation, CAPA and EV systems.
- Perform other duties as required.
- Bachelor’s Degree.
- Minimum 7 years of experience in a quality document management, quality engineering, validation, and quality assurance or quality systems.
- Strong knowledge of GMP, SOPs and quality system processes.
- Excellent organizational skills.
- Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic quality management systems.
- Strong knowledge of change control/deviation practices/strategies
- Strong written and verbal communication skills.
- Ability to communicate and work independently with scientific/technical personnel.
- Experience in pharmaceutical or bio-pharmaceutical field.
- Education or training in cell culture and gene therapy manufacturing environment a plus.
- Proficient in drafting and completing technical documents and presentations.
- Quality systems demonstrated knowledge in areas such as change control, deviation, CAPA and EV systems management.
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
- The standard work week for this position is M-F with occasional weekend work required.
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.