About the job
Join Kyowa Kirin, a rapidly expanding global specialty pharmaceutical company, as we harness cutting-edge biotechnologies to innovate and deliver groundbreaking therapies across four key medical fields: bone and mineral health, challenging hematologic conditions, hematology oncology, and rare diseases. With our headquarters in Princeton, NJ, and offices throughout California, North Carolina, and Mississauga, Ontario, our mission is to transform scientific discoveries into impactful treatments where options are limited.
The Senior Specialist, Quality Assurance Learning Management System (LMS) position is vital to the development and operation of our Quality Learning and Development program at our new monoclonal antibody drug substance manufacturing facility in Sanford, NC. In this role, you will be instrumental in establishing an exemplary training framework, ensuring adherence to regulatory standards, and fostering a culture of continuous improvement.
Initially immersed in a greenfield setting, you will transition to providing comprehensive technical and quality oversight across various functions, ensuring our Site Training Program aligns with global regulatory mandates, including 21 CFR Part 11 and EU Annex 11, while upholding data integrity standards (ALCOA++). Collaborating closely with area management and Training Coordinators, you will support GMP-readiness, tech transfer, and facility licensure efforts for our Phase III and commercial products.
Your leadership in training activities, system enhancements, user support, and audit preparedness will be critical. You will partner with Quality, HR, Operations, and functional training champions to guarantee that all employees receive appropriate training, maintain accurate records, and support Kyowa Kirin’s commitment to delivering high-quality products consistently.
As an individual contributor, you will adopt a compassionate, people-centric approach, fostering a supportive and inclusive workplace. Your strong interpersonal skills will enable you to collaborate effectively with diverse perspectives, manage relationships thoughtfully, and make decisions that prioritize both individual and team needs. You will be accountable for achieving results, adapting to challenges, and pursuing business objectives. Taking ownership of your responsibilities, you will proactively seek opportunities for personal and professional growth while adeptly navigating change in a dynamic environment, always keeping patient needs at the forefront.
This position reports directly to the Senior Manager of Quality Assurance.