Sr. Specialist, Quality Assurance LMS

About the role

Kyowa Kirin North America is hiring a Sr. Specialist, Quality Assurance LMS in Sanford, NC, to help start up and run the Quality Learning and Development program at its new monoclonal antibody drug substance manufacturing facility. The role works in a greenfield environment and moves toward technical and quality oversight across functions, ensuring compliance with regulatory and procedural requirements within the Site Training Program. It reports to the Senior Manager, Quality Assurance.

Key responsibilities

• Maintain site training curricula, assignments and training plans, track completions, monitor overdue training and build courses
• Ensure configuration and changes comply with electronic records/e-signature and data integrity requirements, and run routine system health checks and compliance assessments
• Create, update and retire curricula, qualification programs and retraining matrices, and support Instructor-Led Training setup in Veeva
• Distribute training compliance reports, monitor overdue training and onboarding progress, and act as the training contact during FDA, EMA, MHRA and Health Canada inspections and internal audits
• Keep electronic Veeva audit trails and logs complete and retrievable, and maintain LMS job aids and How-To resources
• Support validation activities and cross-functional change control related to training
• Design interactive eLearning, video-based training and job aids with tools such as Articulate Storyline, Rise or Camtasia
• Provide Veeva expertise to GxP operations and drive continuous improvement of training processes and LMS workflows

Required profile

• Bachelor's degree in Life Sciences, Training & Development, Quality or a related field (or equivalent experience)
• 5+ years managing or administering an LMS including instructional design in a regulated industry (pharmaceutical, biotechnology, medical device)
• Experience in Veeva LMS; familiarity with 21 CFR Part 11, EU Annex 11 and GMP training principles
• Strong data entry, reporting, document standards and system administration skills
• Preferred: QA, Training, Talent Development or Document Control experience in a GMP setting, and experience starting up a biopharma manufacturing facility

Required skills

• Veeva LMS
• Articulate 360, Camtasia, Canva
• MS Office Suite