Senior Specialist, Digital Quality (Quality Systems & Compliance)

The role

The Senior Specialist, Digital Quality serves as the Quality business lead and system owner for laboratory digital systems. This role ensures laboratory computerized systems remain compliant, validated, and aligned with regulatory requirements at the Sanford, NC manufacturing site.

What you will do

• Serve as Quality System Owner and Business Administrator for LabVantage LIMS and associated laboratory computerized systems
• Partner with IT, laboratory operations, Automation, Engineering, global teams, and system vendors to manage system lifecycles
• Translate laboratory and compliance requirements into user requirements and system configurations
• Maintain system ownership and lifecycle documentation including validation plans and risk assessments
• Author, review, and approve computerized system validation deliverables
• Lead and coordinate system periodic reviews, user access reviews, and audit trail review governance
• Partner with IT and vendors to manage incidents, deviations, CAPAs, and change controls
• Provide Quality oversight for analytical instrument software and associated interfaces
• Support the implementation, validation, and integration of analytical instruments with LIMS and other platforms
• Monitor and communicate system health, compliance risks, and quality metrics to leadership

Required qualifications

• Bachelor’s degree in Life Sciences, Information Systems, Computer Science, Engineering, or a related scientific or technical discipline
• Minimum of 5 years of experience in a GxP-regulated pharmaceutical, biotechnology, or related life sciences environment
• Demonstrated experience serving as a system owner, business administrator, validation lead, or Quality representative for GxP computerized systems
• Experience supporting analytical instrument qualification, analytical instrument software validation, system integration, and lifecycle management
• Demonstrated experience in computerized system validation
• Experience partnering with Information Technology teams, vendors, and business stakeholders
• Experience managing deviations, investigations, CAPAs, change controls, periodic reviews, user access reviews, and audit readiness activities
• Demonstrated written and verbal communication skills

Nice to have

• Master’s degree in 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

Benefits

• 401K with company matching
• Annual Bonus Program
• 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
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

About the company

Kyowa Kirin is a global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation. The company works across the continuum from drug discovery to commercialization.