Specialist III, Quality Assurance Operations

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization.

In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

The Quality Assurance Operations Specialist III plays a pivotal role in the launch and ongoing operations of the Quality Assurance organization at Kyowa Kirin’s new monoclonal antibody drug substance manufacturing facility in Sanford, NC. Starting in a greenfield environment, you will help establish QA systems and processes, then transition into providing technical leadership through GMP readiness, technology transfer, and facility licensure for late clinical and commercial products.

You will ensure that all GxP areas within the Site Operations maintain full compliance with current GxP standards and all applicable global, regional, and site procedures within Kyowa Kirin’s Quality Management System. This 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 help ensure the site operates with excellence, integrity, and accountability.
• Act as an individual contributor while collaborating with others to create a supportive and inclusive environment aligned with the organization’s values.
• Deliver results, adapt to challenges, take ownership of tasks, and seek opportunities to learn and grow while staying patient-centric in a fast-paced environment.
• Report to the Senior Manager, Quality Assurance.
• Ensure data integrity and regulatory compliance, including ALCOA+ for paper and electronic records and 21 CFR Part 11.

• Bachelor’s degree in Life Sciences, Chemical Engineering, Pharmaceutical Sciences, Quality Assurance, or a related discipline required.
• Advanced degree (e.g., 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 (Document Control, Training, Inspections, Batch Disposition, Shop Floor QA, Laboratory QA, Vendor Qualification, and Incoming Quality Assurance).
• Experience with Veeva in Document Management, Deviation, CAPA, Training, and Change Control is preferred.
• Experience executing QA activities related to supplier qualification, including onboarding, monitoring, and recertification.
• Proficient in MS Office and in using Quality Management Systems for documentation, workflow management, and compliance tracking.
• Ability to work in a regulated manufacturing environment, including construction/start-up phases, with appropriate PPE.

• Apply advanced QA expertise across GxP operations to support compliant manufacturing and achieve production goals.
• Independently execute batch record reviews, participate in Gemba walks, coordinate alarm responses, and conduct logbook audits to uphold operational integrity and regulatory compliance.
• Participate in batch disposition and support final product release by verifying documentation and quality standards.
• Review and approve Change Controls, CAPAs, and Deviations in Veeva to ensure timely execution and regulatory alignment.
• Identify and escalate discrepancies within…