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.