Senior Manager Change Control - Quality Systems
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.
Sr. Manager Change Control – Quality Systems
Job Description: Provide oversight and manage changes to Kite’s corporate Quality Computerized Systems. This position will be located at the Kite headquarters and perform as leader in Kite’s Quality Engineering department by ensuring changes are planned, authorized, implemented and tested in compliance with all applicable procedures. Support system – and business owners in assessment of regulatory and quality risks posed by proposed changes. Ensure accuracy and completeness of system inventories, change records, supporting documentation and procedures. Interface and build strong partnerships with IT, Engineering, Manufacturing, R&D and other parts of Kite’s Quality organization.
- Participate in – and manage change control meetings.
- Oversee change implementation and documentation.
- Ensure change control conformance to regulations and quality policies.
- Manage the change control system workflow and ensure maintenance and approval of related documents.
- Support regulatory inspections and audits.
- Establish and manage risk assessment process for system changes.
- Support vendor qualification and – compliance audits.
- Review technical/investigation reports as appropriate.
- Review and approve proposed changes to systems and procedures, as appropriate.
- Track, review and report metric information for use in continuous improvement of areas of responsibility.
- Perform other duties as required.
Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles.
Excellent analytical skills and strong knowledge of GMP, SOPs and quality systems.
Identifying, writing, evaluating and closing changes and experience with internal and external audit principals.
Familiarity with aseptic manufacturing processes.
Strong knowledge of change control practices/strategies.
Computer System Validation.
Proficient in MS Word, Excel, Power Point and other applications.
Strong written and verbal communication skills. Ability to communicate and work independently with scientific/technical personnel.
Minimum of 8 years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, ICH 10).
Minimum of 3 years of management experience.
Bachelor’s degree in technical discipline (Computer Science/Engineering or similar).
Experience in the medical and/or pharmaceutical industry.
ASQ, Black Belt/Green Belt certifications.