Senior Specialist, Digital Quality (Quality Systems & Compliance)

Kyowa Kirin•Sanford, NJ

1d•Onsite

About The Position

The Senior Specialist, Digital Quality 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, North Carolina manufacturing site. The role ensures laboratory computerized systems remain compliant, validated, inspection-ready, and aligned with applicable regulatory requirements, including 21 CFR Part 11, EU Annex 11, ALCOA++, and data integrity standards. Working with IT, QC Operations, Automation, Engineering, system vendors, and global stakeholders, the position oversees system lifecycle management, validation, change control, user access, periodic reviews, enhancements, and continuous improvement. As business administrator for LabVantage and related systems, the incumbent translates business requirements into compliant digital solutions, supports integrations and investigations, and helps ensure reliable use of laboratory data and technology. The 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. It is an on-site role in Sanford, NC, in office and regulated manufacturing environments, including construction and start-up phases, with appropriate PPE. Travel may be required, up to 5–10% domestically and limited internationally.

Requirements

Bachelor’s degree in Life Sciences, Information Systems, Computer Science, Engineering, or a related scientific or technical discipline.
At least 5 years of experience in a GxP-regulated pharmaceutical, biotechnology, or related life sciences environment, focused 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).
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 IT teams, vendors, and business stakeholders to implement, administer, maintain, and improve GxP systems.
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 for GxP systems.
Experience supporting regulatory inspections or audits involving laboratory computerized systems, validation, or data integrity.
Demonstrated written and verbal communication skills, including the ability to author SOPs, training materials, governance documents, and technical reports.

Nice To Haves

Master’s degree in a related scientific or technical discipline.
Hands-on experience with LabVantage.
Experience with laboratory informatics ecosystems, including LIMS, chromatography data systems such as Empower, analytical instrument software, interfaces, and master data governance.
Experience supporting facility start-up, system implementation, technical transfer, or operational readiness activities.

Responsibilities

Serve as Quality System Owner and Business Administrator for LabVantage LIMS and associated laboratory computerized systems, ensuring they remain compliant, validated, fit for intended use, and aligned with business requirements.
Partner with IT, laboratory operations, Automation, Engineering, global teams, and vendors to manage system implementation, configuration, validation, maintenance, upgrades, integrations, and retirement.
Translate laboratory and compliance requirements into user requirements, system configurations, enhancements, and sustainable operational solutions.
Maintain system ownership and lifecycle documentation, including user requirements, inventories, data flow diagrams, validation plans, risk assessments, traceability documentation, periodic reviews, and 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.
Ensure laboratory computerized systems comply with data integrity, electronic records, and electronic signatures requirements, including 21 CFR Part 11, EU Annex 11, ALCOA++, and applicable procedures.
Lead and coordinate periodic system reviews, user access reviews, audit trail review governance, backup and recovery assessments, and other controls needed to maintain the validated state and inspection readiness.
Partner with IT and vendors to manage incidents, deviations, CAPAs, change controls, enhancements, upgrades, cybersecurity activities, and service delivery affecting GxP laboratory systems.
Provide Quality oversight and business administration for analytical instrument software and interfaces to ensure secure, reliable, and compliant generation, processing, review, retention, and retrieval of laboratory data.
Support 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 stakeholders.
Serve as a subject matter expert during regulatory inspections, client audits, and internal audits involving 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 for digital quality systems.
Deliver training, coaching, and ongoing business support to system users and administrators to promote consistent, compliant, and effective use of laboratory digital systems.
Set clear objectives, manage priorities, and deliver measurable outcomes aligned with organizational goals.
Navigate ambiguity and change while maintaining accountability, responsiveness, and attention to detail.
Build productive relationships through clear communication, active listening, and inclusive collaboration across diverse teams and cultures.
Promote continuous learning and knowledge sharing, and apply an enterprise-wide perspective to identify opportunities, drive innovation, and deliver integrated solutions.

Benefits

401(k) with company matching
Annual bonus program
Generous paid time off and holiday schedule, including summer and winter shutdowns, sick days, and volunteer days
Healthcare benefits, including medical, dental, prescription drug, and vision coverage
HSA and FSA programs
Well-being and work/life programs
Long-term incentive program, subject to job level and performance
Life and disability insurance
Concierge service
Pet insurance
Tuition assistance
Employee referral awards