Specialist III, Quality Assurance Operations

Overview

Join Kyowa Kirin, Inc.

- U.S. as a Specialist III, Quality Assurance Operations. This role is pivotal in launching and operating the Quality Assurance organization at the new monoclonal antibody drug substance manufacturing facility in Sanford, NC. Candidates will establish QA systems in a greenfield environment and later provide technical leadership through GMP readiness, technology transfer, and facility licensure for late clinical and commercial products.

The role offers a unique opportunity to shape a culture of quality from the ground up while contributing to the delivery of life‑changing therapies.

• Execute core QA activities such as batch record review, product disposition, and oversight of warehouse, laboratory, and supplier operations.
• Collaborate cross‑functionally to monitor site quality metrics, investigate deviations, and support continuous improvement initiatives.
• Leverage the Global Quality Management System in Veeva to ensure alignment with regulatory requirements, including data integrity standards.
• Participate in regulatory inspections and lead quality culture initiatives to maintain site excellence, integrity, and accountability.
• Act as an individual contributor with compassionate, people‑focused approach, proactively collaborating to create a supportive and inclusive environment.

• Advanced knowledge and expertise across GxP operations to support compliant manufacturing and achieve production goals.
• Independent execution of batch record review, Gemba walks, alarm responses, and logbook audits to uphold operational integrity and regulatory compliance.
• Support batch disposition and final product release by verifying documentation and quality standards for timely, compliant delivery.
• Support Warehouse and Incoming Quality activities to ensure materials meet defined specifications and quality requirements.
• Review and approve Change Controls, CAPAs, and Deviations in Veeva to ensure timely execution and regulatory alignment.
• Lead investigations of non‑conformances, deviations, laboratory exceptions, and cGMP issues; initiate CAPAs and communicate resolution plans.
• Conduct Supplier Quality activities including onboarding, monitoring, and recertification to maintain alignment with internal and external quality standards.
• Partner with Quality Control to ensure laboratory operations meet cGMP standards and support consistent, high‑quality testing practices.
• Monitor and analyze site quality metrics—including Deviations, CAPAs, Change Controls, OOS, Invalid Assays, OOT, Equipment Failures, EM data trends, Stability Trends, and Product Disposition Cycle‑times—to identify trends and support continuous improvement.
• Maintain site Quality Management System procedures within Veeva, aligning with the global QMS structure.
• Champion a culture of quality in all GxP areas within Site Operations by providing subject matter expertise focused on patient‑centric practices, sustainable compliance, and inspection readiness.

• Bachelor’s degree in Life Sciences, Chemical Engineering, Pharmaceutical Sciences, Quality Assurance, or a related discipline required.
• Advanced degree (Master’s in Regulatory Affairs, Biotechnology, or Quality Systems) preferred.

• 3–5 years of experience in Quality Assurance within biopharmaceutical manufacturing, executing technical and compliance activities across GMP QA functions including Document Control, Training, Inspections, Batch Disposition, Shop Floor QA, Laboratory QA, Vendor Qualification, and Incoming Quality Assurance.
• Assisted with QA batch disposition and final product release by verifying documentation accuracy and ensuring alignment with regulatory standards.
• Reviewed and approved batch records, conducted Gemba walks, responded to alarms, and audited logbooks to maintain operational integrity and compliance.
• Executed QA activities related to warehouse operations and incoming material inspections, verifying adherence to cGMP requirements and internal procedures.
• Reviewed and approved Change Controls, CAPAs, and Deviations, ensuring timely resolution and alignment with quality and regulatory expectations.
• Led investigations of…