Sr. Specialist, Quality Assurance LMS
The Sr. Specialist, Quality Assurance LMS at Kyowa Kirin North America is integral to the establishment and operation of the Quality Learning and Development program at the new monoclonal antibody drug substance manufacturing facility in Sanford, NC. This role involves transitioning from a greenfield environment to providing technical and quality oversight, ensuring compliance with regulatory and procedural requirements within the Site Training Program. The position collaborates closely with area management and Training Coordinators throughout GMP readiness, tech transfer, and facility licensure activities for manufacturing Phase III and commercial products.
Key responsibilities include maintaining site training curricula, assigning and tracking training completions, and building courses. The role ensures that training processes comply with global regulatory requirements, including 21 CFR Part 11, EU Annex 11, and data integrity standards. Additionally, the Sr. Specialist leads site training activities, system enhancements, user support, and audit readiness, partnering with Quality, HR, Operations, and functional training champions to ensure employees are properly trained and records are accurate.
The ideal candidate holds a bachelor's degree in Life Sciences, Training & Development, Quality, or a related field, with over five years of experience managing or administrating Learning Management Systems (LMS) in a regulated industry such as pharmaceutical, biotechnology, or medical device sectors. Proficiency in Veeva LMS, familiarity with 21 CFR Part 11, EU Annex 22, and GMP training principles are essential. Strong skills in data entry, reporting, document standards, and system administration, along with excellent organizational, analytical, and communication abilities, are required.
The anticipated salary for this position ranges from $116,000 to $174,000 annually. Kyowa Kirin North America offers a comprehensive benefits package, including a 401(k) with company matching, annual bonus program, generous PTO and holiday schedule, healthcare benefits (medical, dental, prescription drugs, and vision), HSA & FSA programs, well-being and work/life programs, long-term incentive program, life and disability insurance, concierge service, pet insurance, tuition assistance, and employee referral awards.
Kyowa Kirin North America fosters a collaborative and inclusive work environment, emphasizing innovation, diversity, integrity, and a patient-focused approach. Employees are encouraged to take ownership of their tasks, act with initiative, and continuously seek opportunities for learning and growth. The company values strong interpersonal skills, adaptability, and a commitment to delivering high-quality products that make a meaningful impact on patients' lives.