Quality Systems & Compliance, Digital Lead

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 Systems & Compliance, Digital Lead plays a critical role in ensuring adherence to global regulatory requirements—including 21 CFR Part 11, EU Annex 11, and data governance and integrity standards—during the design, implementation, and integration of GxP computerized and automated systems at Kyowa Kirin’s new North American monoclonal antibody drug substance manufacturing facility in Sanford, NC. Initially operating in a greenfield environment, this role evolves into a key technical contributor within the Quality Systems & Compliance team, driving GMP readiness, technical transfer, and facility licensure activities for clinical and commercial manufacturing.

As the technical quality lead, you will influence compliance strategies across the lifecycle of cGxP computerized systems, partnering with designated system owners and cross-functional teams to ensure validation, inspection readiness, and regulatory alignment. You will lead site-wide efforts to prepare for audits and inspections, manage regulatory response activities, and serve as a subject matter expert in automation, digital platforms, and data integrity. Additionally, you will own training and capability-building initiatives for all site colleagues, fostering a culture of quality, collaboration, and operational excellence.

As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.

This position reports to the Sr. Manager, Quality Systems & Compliance

Technical Skills, Knowledge, and Experience 
•    Drive the implementation and validation of automation and technology systems—including ERP, MES, LIMS, and site infrastructure—by aligning with global, regional, and site teams to meet internal and external regulatory requirements (e.g., FDA, EMA, ICH), uphold patient-centric principles, and maintain continuous inspection readiness across all GxP areas.
•    Lead cross-functional collaboration across all site functions to design and execute automation strategies that accelerate digital transformation and enhance operational efficiency in manufacturing, laboratory, engineering, warehouse, and quality operations.
•    Designs and optimizes automated workflows to achieve business objectives, ensure global regulatory compliance, and optimize performance across GxP operations.
•    Establish and enforce the site’s data governance framework by defining master data management protocols, metadata standards, and data lifecycle controls to ensure consistent, compliant, and high-quality data across all digital platforms.
•    Monitor and communicate progress on Quality Systems goals by delivering performance reports and presenting actionable insights to the Site Leadership Team and stakeholders, enabling informed decision-making and continuous improvement.
•    Shape Quality IT strategies and system selection processes during early-stage site activities by defining user requirements, evaluating system options, and influencing procurement decisions to ensure electronic systems meet compliance and operational needs.
•    Ensure site-wide compliance with global data integrity standards (e.g., ALCOA++, 21 CFR Part 11) by leading the design, implementation, and integration of GxP electronic systems in coordination with Global and Regional teams, aligned with approved plans and budgets.
•    Apply robust risk management methodologies to ensure systems comply with global, regional, and site procedures by documenting risk-based decisions with sound rationales, factual evidence, and relevant data to pro