Administrator, Quality System Document Management - United States
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.
Administrator, Quality System Document Management
Job Purpose: Provide administration of Kite’s document management system, Document Locator. This position will be located at the Kite headquarters and will establish and maintain the process and procedures for management and maintenance of the system’s workflows/configuration. Interface and build strong partnerships with IT, Engineering, Manufacturing, R&D and other parts of Kite’s Quality organization.
- Manage the configuration of Document Locator in collaboration with the system owner in compliance with internal procedures and policies as well as regulatory requirements.
- Manage the workflows for routing, review, approval, distribution and archival of new and revised controlled documents. Manage established user groups and periodically review access/security and audit trails.
- Provide system specific support and troubleshooting for IT trouble tickets. Escalate issues as needed to the next support level with the system supplier.
- System administration point of contact for IT and the system supplier.
- Develop and maintain system administration procedures, training and guidance on document and records management roles, and processes.
- Support system upgrades and – changes with technical expertise and hands on implementation and test activities as needed.
- Participate in Kite’s system administration center of excellence and establish best practices.
- Support regulatory audits as needed.
- Work on multiple assignments in collaboration with various department system owners.
Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles. Excellent analytical skills Strong knowledge of GMP, SOPs and quality systems. Excellent computer system administration and configuration skills. Computer System Validation. Multitasking and prioritization skills. Advanced Skills with MS Office applications Word, Excel, Access, as well as Adobe Acrobat. Strong written and verbal communication skills Ability to communicate and work independently with scientific/technical personnel
Required: 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 3-5 years of management experience. Education: Bachelor’s degree in technical discipline (Computer Science/Engineering or similar). Preferred: Experience in the medical and/or pharmaceutical industry. ASQ, Black Belt/Green Belt certifications.