Specialist III, Quality Assurance Governance

Specialist III, Quality Assurance Governance

Sanford, NC

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.

As the Specialist III – Quality Assurance Governance, you will play a critical role in the start‑up and ongoing operations of the QA organization at Kyowa Kirin’s new monoclonal antibody drug substance manufacturing facility in Sanford, NC.

You will begin in a greenfield environment, where you will help establish foundational QA systems and processes. As the site progresses through GMP readiness, technology transfer, and facility licensure for late clinical and commercial manufacturing, you will provide technical leadership to ensure quality and compliance are embedded in every step.

• Ensure that all GxP areas within Site Operations comply with current GxP standards and all applicable global, regional, and site procedures within Kyowa Kirin’s Quality Management System.
• Design and execute governance frameworks that guide how quality is managed across the site — ensuring consistency, data integrity, and inspection readiness.
• Manage core QA systems such as Change Control, CAPAs, Deviations, Document Control, and Training, helping build a sustainable quality culture rooted in operational excellence, continuous improvement, and patient focus.
• Proactively collaborate with teams to create a supportive and inclusive environment, using strong interpersonal skills to manage relationships thoughtfully and make decisions that meet both individual and team needs.
• Deliver technical expertise in QA 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.
• Maintain site procedures within the Global Quality Management System structure in Veeva, ensuring alignment with internal standards and regulatory expectations.
• Provide subject matter expertise to foster a robust culture of quality focused on patient‑centric practices, sustainable compliance, and inspection readiness across all GxP areas.
• Identify and expedite discrepancies or non‑compliant entries within the Quality Management System, collaborating with process owners to resolve issues and ensure records meet regulatory and internal standards.
• 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.
• Define and monitor key performance indicators for 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 drive continuous improvement.
• Ensure compliance with current regulatory requirements for Data Integrity (ALCOA+) as applicable to both paper and electronic records, including 21 CFR Part 11.
• Communicate progress against goals across functions, to the Site Leadership Team, and to key stakeholders to ensure alignment and accountability.
• Participate in regulatory inspections by demonstrating site compliance and executing QA activities aligned with inspection‑readiness expectations.

• Bachelor’s degree in Life Sciences, Engineering, or a related field required.
• Advanced degree (e.g., Master’s in Quality, Regulatory Affairs, or Biotechnology) preferred.

• At least 3‑5 years of experience in QA within…