Document Control 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 Document Control Manager. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the Associate Director of Quality Systems.
The Document Control Manager will provide oversight of Kite’s clinical GMP Document and Records Management system. This position will be located at Kite’s clinical manufacturing site in Santa Monica, and will establish the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site. This involves writing and maintaining document control procedures and participating in the development and roll-out of document control tools. Additional job duties include:
- Manage document control processes and systems for GMP activities in compliance with internal procedures and policies as well as regulatory requirements.
- Manage the routing, review, approval, distribution and archival of new and revised controlled documents.
- Ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedures.
- Establish and maintains records management system including secure storage, retrieval, retention and destruction.
- Develop and deliver training and/or site guidance on document and records management roles, and processes.
- Define resource requirements; assign resources to tasks; manage assigned team.
- Bachelor’s degree preferred or minimum of 5-7 years of experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
- Knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
- Minimum of 2-3 years of management experience.
- Strong knowledge of GMP, SOPs and quality systems.
- Excellent writing and editing skills.
- Works on multiple assignments in collaboration with various department system owners.
- Advanced skills with MS Office applications Word, Excel, Access, as well as Adobe Acrobat.
- Ability to communicate and work independently with scientific/technical personnel.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
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.