Sr. Specialist, Quality Assurance LMS (Learning Management Systems)
Sanford, NC Remote
$112,500–$131,000 a yearJobFig found this opening at its original source and checks that it remains available.
About the role
The Sr. Specialist, Quality Assurance LMS position will play a critical role in the start-up, and operations of the Quality Learning and Development program within the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford, NC. You will initially work in a greenfield environment and will transition to provide technical and quality oversight cross-functionally; ensuring compliance with regulatory and procedural requirements within the Site Training Program. This role will be working in close collaboration with area management and Training Coordinators throughout the GMP-ready, Tech Transfer, and facility licensure activities for the manufacturing Phase III and commercial products. This role ensures that training processes remain compliant with global regulatory requirements, including 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA ++) standards, while leading site training activities, system enhancements, user support, and audit readiness. The LMS Administrator partners closely with Quality, HR, Operations, and functional training champions to ensure employees are properly trained, records are accurate, and all training activities support Kyowa Kirin’s mission to reliably supply high quality products. As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values.
What you'll bring
- Bachelor’s degree in Life Sciences, Training & Development, Quality, or related field (or equivalent experience).
- Five + years of experience managing or administrating the LMS (Learning Management Systems) including Instructional Design in a regulated industry (pharmaceutical, biotechnology, medical device).
- Experience in Veeva LMS.
- Familiarity with 21 CFR Part 11, EU Annex 22, and GMP training principles.
- Demonstrated and strong proficiency in data entry, reporting, document standards, and system administration.
- Excellent organizational, analytical, and communication skills.
- Prior experience in QA, Training, Talent Development, or Document Control within a GMP setting.
- Knowledge of pharmaceutical quality systems and training lifecycle management.
- Experience using and managing Veeva.
- Experience working within Learning and Development at a manufacturing site location.
- Experience with starting up and operating a biopharma manufacturing facility is a plus.
- Proficient in MS Office Suite