Senior Specialist, Digital Quality (Quality Systems & Compliance)

Kyowa Kirin is a global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation, dedicated to discovering and advancing treatments for diseases in which unmet need is greatest. Based in Japan with worldwide operations, we work across the continuum from drug discovery to commercialization, guided by our commitment to patients and their families. Our research teams, located in California and around the world, are focused on developing the next generation of antibody, cell, and gene therapies, with particular emphasis on bone and mineral disorders, hemato-oncology, and rare diseases. We accelerate development through collaborations with industry, academia, patients, and healthcare providers, and since 2018 we have introduced four new therapies serving patients with progressive illnesses often in need of new therapeutic alternatives. Our culture is grounded in our values: Commitment to Life, Integrity, Innovation, and Teamwork/Wa, and brought to life through the Kabegoe Principles, which define the behaviors and actions that guide how we work together to deliver meaningful impact for patients. We’re proud of the progress we’ve made and mindful of the countless individuals still waiting for their own breakthroughs. A commitment to making people smile unites our efforts. Learn more at www.kkna.kyowakirin.com. Summary: The Senior Specialist, Digital Quality (Quality Systems & Compliance) serves as the Quality business lead and system owner for laboratory digital systems, including LabVantage LIMS, analytical instrument platforms, and related interfaces supporting GxP operations at Kyowa Kirin’s Sanford, NC manufacturing site. This role ensures laboratory computerized systems remain compliant, validated, inspection-ready, and aligned with regulatory requirements, including 21 CFR Part 11, EU Annex 11, ALCOA++, and data integrity standards. Partnering with IT, QC Operations, Automation, Engineering, system vendors, and global stakeholders, the incumbent oversees system lifecycle management, validation, change control, user access, periodic reviews, enhancements, and continuous improvement. As the business administrator for LabVantage and related systems, this role translates business requirements into compliant digital solutions, supports system integrations and investigations, and ensures the reliable use of laboratory data and technology. This position reports to the Sr. Manager, Quality Systems & Compliance and receives day-to-day Digital Quality priorities, technical direction, and workstream alignment from the Digital Quality Lead, as applicable. Essential Functions: Technical Skills, Knowledge, and Experience • Serve as Quality System Owner and Business Administrator for LabVantage LIMS and associated laboratory computerized systems, ensuring systems remain compliant, validated, fit for intended use, and aligned with business requirements. • Partner with Information Technology, laboratory operations, Automation, Engineering, global teams, and system vendors to manage the lifecycle of laboratory digital systems, including implementation, configuration, validation, maintenance, upgrades, integrations, and retirement. • Act as the primary Quality business representative for laboratory digital platforms by translating laboratory and compliance requirements into user requirements, system configurations, enhancements, and sustainable operational solutions. • Maintain system ownership and lifecycle documentation, including user requirements, system inventories, data flow diagrams, validation plans, risk assessments, traceability documentation, periodic reviews, and system governance records. • Author, review, and approve computerized system validation deliverables, including protocols, test scripts, reports, risk assessments, deviations, and technical documentation, using a risk-based approach and ensure laboratory computerized systems comply with data integrity and electronic records and electronic signatures requirements, including 21 CFR Part 11, EU Annex 11, ALCOA++, and applicable global, regional, and site procedures. • Lead and coordinate system periodic reviews, user access reviews, audit trail review governance, backup and recovery assessments, and other controls required to maintain the validated state and inspection readiness. • Partner with IT and vendors to manage incidents, deviations, corrective and preventive actions, change controls, enhancements, upgrades, cybersecurity activities, and service delivery affecting GxP laboratory systems. • Provide Quality oversight and business administration for analytical instrument software and associated interfaces to ensure secure, reliable, and compliant generation, processing, review, retention, and retrieval of laboratory data. • Support the implementation, validation, and integration of analytical instruments with LIMS, chromatography data systems, and other enterprise platforms while maintaining data integrity and intended-use requirements. • Collaborate with laboratory subject matter experts and process owners to optimize workflows, standardize master data and system use, improve data management practices, and implement technology-enabled process improvements. • Monitor and communicate system health, compliance risks, project status, service performance, and quality metrics to Quality leadership and relevant stakeholder and serve as a subject matter expert during regulatory inspections, client audits, and internal audits for LIMS, analytical instrument systems, computerized system lifecycle controls, and laboratory data integrity. • Author, review, and maintain procedures, work instructions, governance documents, system administration guides, and training materials related to digital quality systems and deliver training, coaching, and ongoing business support to system users and administrators to promote consistent, compliant, and effective use of laboratory digital systems. Non-Technical Skills: Demonstrates a results-oriented approach by setting clear objectives, managing priorities, and delivering measurable outcomes aligned with organizational goals. Navigates ambiguity and change effectively while maintaining accountability, responsiveness, and attention to detail. Builds productive relationships through clear communication, active listening, and inclusive collaboration across diverse teams and cultures. Promotes a growth mindset through continuous learning and knowledge sharing. Applies an enterprise-wide perspective to identify opportunities, drive innovation, and deliver integrated solutions that support business success. Requirements: Education • Bachelor’s degree in Life Sciences, Information Systems, Computer Science, Engineering, or a related scientific or technical discipline (required). Master’s degree in related scientific or technical discipline (preferred). Experience • Minimum of 5 years of experience in a GxP-regulated pharmaceutical, biotechnology, or related life sciences environment, with a focus on Quality Assurance for computerized systems, laboratory systems, or digital platforms. • Demonstrated experience serving as a system owner, business administrator, validation lead, or Quality representative for GxP computerized systems. • Experience with Laboratory Information Management Systems (LIMS); hands-on experience with LabVantage is strongly preferred. • Experience supporting analytical instrument qualification, analytical instrument software validation, system integration, and lifecycle management. • Demonstrated experience in computerized system validation, including authoring or reviewing user requirements, protocols, test scripts, risk assessments, traceability documentation, and validation reports. • Experience partnering with Information Technology teams, vendors, and business stakeholders to implement, administer, maintain, and improve GxP systems, along with a strong understanding of data integrity requirements, electronic records and electronic signatures, 21 CFR Part 11, EU Annex 11, ALCOA++, and global regulatory expectations for computerized systems. • Experience managing deviations, investigations, CAPAs, change controls, periodic reviews, user access reviews, and audit readiness activities associated with GxP systems, and experience supporting regulatory inspections or audits involving laboratory computerized systems, validation, or data integrity. • Experience with laboratory informatics ecosystems, including LIMS, chromatography data systems such as Empower, analytical instrument software, interfaces, and master data governance, preferred, and experience supporting facility start-up, system implementation, technical transfer, or operational readiness activities is highly desirable. • Demonstrated written and verbal communication skills, with the ability to author SOPs, training materials, governance documents, and technical reports. Physical Demands: Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law. This position is an on-site role based in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. Working Conditions: May require up to 5-10% domestic and limited international travel. The anticipated salary for this position will be $130,500 to $150,000. 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. The listed salary is just one component of the overall compensation package. 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 [email protected]. Controller’s data protection officer can be contacted at [email protected]. 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 [email protected]. Recruitment & Staffing Agencies Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. 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