Quality Assurance

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: 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. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts. Essential Functions: Technical Skills, Knowledge, And Experience Maintain the site training curricula, and training assignments and assign training, track training completions, monitor overdue training events, reconcile overdue training, and build courses. Ensure configuration and changes comply with electronic records/e-signature requirements and data integrity principles and perform routine system health checks, periodic reviews, and compliance assessments, and troubleshoot LMS issues and coordinate with IT and Veeva Vault Training support teams as needed. Create, update, and retire curricula, training plans, qualification programs, and retraining matrices and coordinate setting up for Instructor-Led Training Courses (ILTs) in Veeva and support instructors with scheduling and logistics and 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 training progress. Maintain accurate training records to support inspections (FDA, EMA, MHRA, Health Canada) and internal audits and function as the Training contact in inspections (FDA, EMA, MHRA, Health Canada) and internal audits. Ensure electronic Veeva Training system audit trails and system logs are complete and retrievable for compliance purposes. Maintain LMS job aids, quick reference guides, and "How To" resources for site users and evaluate new LMS features, upgrades, and enhancements, supporting validation activities when required. Support cross functional change control related to training impacts and Design and develop engaging, interactive eLearning, video-based training, and job aids using tools like Articulate Storyline, Rise, or Camtasia. Ensure training records are accurate, audit-ready, and compliant with regulatory standards (FDA, EMA, GxP). Generate compliance reports (KPIs) for Quality Management Review. Provide technical training expertise regarding Veeva to all GxP operations in support of site manufacturing operations. Participate in continuous improvement of training processes and LMS workflows and provide subject matter expertise and leadership to establish a robust culture of quality based on patient-focus, sustainable compliance, and inspection-readiness for GxP training areas within the facility and laboratory areas. Ensure compliance with current regulatory requirements for Data Integrity (ALCOA++) requirements as applicable to paper and electronic records (21 CFR Part 11) Requirements: Education Bachelor’s degree in Life Sciences, Training & Development, Quality, or related field (or equivalent experience). 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. Preferred 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. Technical Skills Proficient in MS Office Suite Proficient in Veeva LMS Proficient in Articulate 360, Captivate, Camtasia, Canva Physical Demands: Initially worked on a construction site and ultimately in a biotech manufacturing site in Sanford, NC. Working Conditions: Work is 100% on-site. This is not a hybrid or remote role. Requires up to 10% domestic and limited international travel. The anticipated salary for this position will be $112,500 to $131,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. At Kyowa Kirin North America we provide a comprehensive range of benefits including: 401K with company matching Annual Bonus Program (Sales Bonus for Sales Jobs) Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) HSA & FSA Programs Well-Being and Work/Life Programs Long-Term Incentive Program (subject to job level and performance) Life & Disability Insurance Concierge Service Pet Insurance Tuition Assistance Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller"), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing View email address on click.appcast.io. Controller’s data protection officer can be contacted at View email address on click.appcast.io. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 ("GDPR") as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at View email address on click.appcast.io. Recruitment & Staffing Agencies Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #Sanford #North Carolina #On-Site #J-18808-Ljbffr