Manager, Quality Systems Training
Quality | Santa Monica, CA | Full Time
Kite is a biopharmaceutical company 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. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
We are seeking a highly motivated individual to join us as a Quality Systems Training Manager. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.
Responsibilities (include but are not limited to):
The Quality Systems Training Manager will serve as the Site Training Representative and provide support of Kite's Quality Systems (Change Control, CAPA and Internal Audits). This position will be located at Kite’s clinical manufacturing site in Santa Monica, CA. Additional job duties include:
- Serve as the site training representative during interactions with other site reps and/or corporate training.
- Evaluate current and future site training needs and plan training programs accordingly.
- Support and lead curriculum management of site personnel.
- Serve as a site subject matter expert (SME) on Kite’s Learning Management System (LMS).
- Ensure training content is periodically reviewed for relevance and accuracy and reflects current practices.
- Collaborate with site functional managers and SMEs on the creation, delivery, and evaluation of new training content (modules, OJT, classroom training).
- Support delivery of technical and/or compliance training to Kite clinical site staff.
- Develop, track, and communicate site metrics to management
- Support New Hire Orientation and Train-the-Trainer training content and delivery.
- Review and approve training procedures, which include, but are not limited to, SOPs, Controlled Forms, and Work Instructions.
- Identify and escalate training compliance gaps.
- Support the implementation, management and maintenance of Kite Pharma Quality Systems.
- Ensure quality system conformance to regulations and quality policies.
- Support Change Control system and ensure proper maintenance and approval of cGMP documents, changes to systems, procedures, methods and submissions to regulatory agencies.
- Support the CAPA system and ensure timely closure and effectiveness of investigations and corrective and preventive actions.
- Conduct effective root cause analysis and implement corrective action and preventative action.
- Support quality assessments of internal operations and suppliers to analyze compliance and assess risk.
- Support external inspections and audits.
- Bachelor’s of science degree with a minimum of 5 years of combined training and technical experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
- Strong knowledge of training processes/systems and regulatory requirements (21 CRF Part 11/210/211).
- Minimum of 2 years of working within a Learning Management System and Quality Systems.
- Good knowledge of GMPs.
- Experience or knowledge of Change Control, CAPA and Audit practices/strategies.
- Excellent customer focus, enabling strong collaboration with various department system owners and functional area managers.
- Ability to communicate and work independently with scientific/technical personnel.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.
- Advanced skills with MS Office applications including Word, Excel, Access and Adobe Acrobat.
- 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.