Quality Systems Manager
Quality | El Segundo, 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 a Quality Systems Manager reporting to the Quality Systems and Compliance Director. Develop and implement quality systems associated with Deviation, CAPA and Effectiveness Monitoring systems. Work closely with SMEs to create and implement workflows and business processes that align with best practices that ensure right first time.
- Establish and maintain a deviation, CAPA and EV management system compliant with regulatory, quality, and Kite requirements.
- Provide guidance and advice on methods, procedures, standardization and requirements associated with the deviation, CAPA and EV systems.
- Responsible for system triage meeting facilitation.
- 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.
- Provide work direction and guidance to staff to assure completion of assigned tasks and other duties.
- Develop and execute strategic initiatives to improve the deviation, CAPA and EV systems.
- Investigate deviations against the quality system and develop effective corrective action plans.
- Develop, implement and deliver training content for deviation, CAPA and EV processes and procedures.
- Track key performance indicators for the deviation, CAPA and EV systems and reports metrics
- Responsible for procedure reviews and facilitating procedure updates for the deviation, CAPA and EV systems.
- Assure personnel are adequately trained in the principals, policies, and procedures of the deviation, CAPA and EV systems.
- Perform other duties as required.
- Bachelor’s Degree.
- Minimum 8 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 and ability to review and update processes or procedures.
- Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic quality management systems.
- 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.
- Expertise in document management processes.
- Quality systems demonstrated knowledge in areas such as 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.