Sr. Specialist, Quality Assurance LMS
About The Position
The Sr. Specialist, Quality Assurance LMS will support the start-up and operation of the Quality Learning and Development program at Kyowa Kirin North America’s monoclonal antibody drug substance manufacturing facility in Sanford, North Carolina. The role begins in a greenfield construction environment and transitions to providing cross-functional technical and quality oversight of the site training program through GMP readiness, technology transfer, and facility licensure for Phase III and commercial products. The role ensures training processes comply with global regulatory and procedural requirements, including 21 CFR Part 11, EU Annex 11, and ALCOA++ data-integrity standards. Working with Quality, HR, Operations, area management, Training Coordinators, and functional training champions, the LMS Administrator supports employee training, accurate training records, system enhancements, user support, and audit readiness. The position is an individual contributor, with potential to lead or coordinate special projects or task teams, and reports to the Senior Manager, Quality Assurance. The position is 100% on-site in Sanford, NC, initially at a construction site and ultimately at the biotech manufacturing site. It requires up to 10% domestic travel and limited international travel.
Requirements
- Bachelor’s degree in Life Sciences, Training & Development, Quality, or a related field, or equivalent experience.
- Five or more years of experience managing or administering Learning Management Systems, including instructional design, in a regulated industry such as pharmaceutical, biotechnology, or medical device.
- Experience with Veeva LMS.
- Familiarity with 21 CFR Part 11, EU Annex 22, and GMP training principles.
- Demonstrated strong proficiency in data entry, reporting, document standards, and system administration.
- Excellent organizational, analytical, and communication skills.
- Proficiency in Microsoft Office Suite, Veeva LMS, and Articulate 360, Captivate, Camtasia, and Canva.
- Ability to work 100% on-site in Sanford, North Carolina.
- Ability to travel up to 10% domestically and limited internationally.
Nice To Haves
- 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 in Learning and Development at a manufacturing site.
- Experience starting up and operating a biopharmaceutical manufacturing facility.
- Equivalent experience in place of the stated bachelor’s degree.
Responsibilities
- Maintain site training curricula and assignments; assign training, track completions, monitor and reconcile overdue training, and build courses.
- Ensure LMS configurations and changes comply with electronic records and electronic-signature requirements and data-integrity principles; perform system health checks, periodic reviews, and compliance assessments; troubleshoot LMS issues and coordinate with IT and Veeva Vault Training support.
- Create, update, and retire curricula, training plans, qualification programs, and retraining matrices.
- Set up Instructor-Led Training courses in Veeva and support instructors with scheduling and logistics; ensure training documentation meets quality and compliance standards.
- Generate and distribute training compliance reports to department leaders and Quality Management; monitor overdue training and onboarding progress; generate KPI reports for Quality Management Review.
- Maintain accurate, audit-ready training records and support or serve as the Training contact during inspections and internal audits, including FDA, EMA, MHRA, and Health Canada inspections.
- Ensure Veeva Training audit trails and system logs are complete and retrievable for compliance purposes.
- Maintain LMS job aids, quick reference guides, and user “How To” resources; evaluate LMS features, upgrades, and enhancements and support validation activities when required.
- Support cross-functional change control related to training impacts.
- Design and develop interactive eLearning, video-based training, and job aids using tools such as Articulate Storyline, Rise, or Camtasia.
- Provide Veeva technical training expertise to GxP operations in support of site manufacturing operations.
- Contribute to continuous improvement of training processes and LMS workflows and provide subject-matter expertise and leadership to support a patient-focused, sustainably compliant, inspection-ready quality culture in GxP training areas and facility and laboratory areas.
- Ensure compliance with current data-integrity requirements, including ALCOA++ and applicable requirements for paper and electronic records under 21 CFR Part 11.
- Potentially lead or coordinate special projects and/or task teams.
Benefits
- 401(k) with company matching.
- Annual bonus program; sales bonus for sales jobs.
- Generous PTO and holiday schedule, including summer and winter shutdowns, sick days, and volunteer days.
- Healthcare benefits, including medical, dental, prescription drugs, and vision.
- HSA and FSA programs.
- Well-being and work-life programs.
- Long-term incentive program, subject to job level and performance.
- Life and disability insurance.
- Concierge service.
- Pet insurance.
- Tuition assistance.
- Employee referral awards.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
