Specialist III, Quality Assurance Governance

As the Specialist III – Quality Assurance Governance, you will play a critical role in the start-up and ongoing operations of the Quality Assurance organization at Kyowa Kirin’s new monoclonal antibody drug substance manufacturing facility in Sanford, NC. You will ensure that all GxP areas within the Site Operations comply with current GxP standards and all applicable global, regional, and site procedures within Kyowa Kirin’s Quality Management System.

Requirements

• Deliver technical expertise in Quality Assurance across all GxP operations to ensure manufacturing activities meet production targets while maintaining full regulatory compliance.
• Manage Quality Management System records in Veeva, including Change Controls, CAPAs, Deviations, and Training, to ensure accurate documentation and timely execution.
• Lead investigations of non-conformances, deviations, laboratory exceptions, and other cGMP issues; initiate and communicate CAPAs to drive effective and compliant identification, prevention, and/or correction of quality issues.

Benefits

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program
• Generous PTO and Holiday Schedule
• Healthcare Benefits
• 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