Global Lead, Quality System Administration
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 Global Lead, Quality System Administration. In this role, you will manage Kite’s Quality System Administrator team and assume ownership of this process. With focus on above site/enterprise systems you ensure compliance with the respective procedures and regulatory guidelines. Provide guidance and support to site based user groups tasked with provision of cell therapy. This position will be located at the Kite headquarters and perform as leader in Kite’s Quality Engineering department. Reporting to Kite’s Head of Quality Engineering you’ll interface and build strong partnerships with IT, Engineering, Manufacturing, R&D and other parts of Kite’s organization.
Responsibilities (include, but are not limited to):
- Oversee quality system administration process for Kite.
- Manage team of Quality System Administrators in Kite’s QE department.
- Oversee configuration management in collaboration with system owners in compliance with internal procedures and policies as well as regulatory requirements.
- Oversee management of system user groups and periodically review access/security and audit trails.
- Manage SLAs and support processes with suppliers of quality systems.
- Develop and maintain system administration procedures, training and guidance on roles and processes.
- Support system upgrades and – changes with technical expertise and hands on implementation and test activities as needed.
- Lead Kite’s system administration center of excellence and establish best practices.
- Support the change control process for validated systems.
- Partner with peers in the QE department around automation strategies.
- Support regulatory inspections and audits.
- Establish and manage risk assessment process for computer system compliance.
- 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.
Department or team management/leadership experience. Quality Assurance, cGMP, Health Authority Regulations and Validation practices/principles. Strong knowledge of cGMP, GAMP, SOPs and quality systems. Experience with internal and external audit principals. Strong knowledge of change control practices/strategies. 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. Excellent analytical skills. 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.
- Bachelor’s degree in technical discipline (Computer Science/Engineering or similar)
- Minimum of 8 years of Computer System Administration 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 7 years of management experience.
Experience in the medical and/or pharmaceutical industry. ASQ, Black Belt/Green Belt certifications.