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 promote transparency, consistency, and audit readiness.
• Partner with all site functions to achieve production targets compliantly across Manufacturing, Warehouse, Engineering, and Laboratory areas by aligning quality processes, resolving operational challenges, and reinforcing adherence to regulatory standards.
• Influence the QA qualification strategy for computerized systems, infrastructure, and automation technologies by guiding cross-functional teams and ensuring systems are validated and ready for commissioning and operational launch in alignment with regulatory and business objectives, while partnering with designated CSV owners to ensure compliance.
• Serve as a core member of the site-based inspection management team by leading timely, compliant responses to regulatory inquiries, coordinating targeted GxP refresher trainings, and conducting regular walkthroughs of GxP areas to proactively identify risks and ensure continuous inspection readiness.
• Deliver site-wide onboarding, training, and mentoring for employees and contractors in accordance with approved staffing plans by providing role-specific guidance, facilitating knowledge transfer, and ensuring readiness to perform in compliance with operational and regulatory standards.
• Define and track key performance indicators in collaboration with Global and Regional teams to assess site performance against QMS requirements and lead periodic site management reviews with the Site Leadership Team to drive continuous improvement and ensure alignment with quality objectives.
• Lead inspection readiness activities across all GxP areas by conducting GEMBA walks and readiness walkthroughs, engaging cross-functional teams to proactively identify and resolve gaps, and driving timely completion of action plans from audits, inspections, or risk mitigation efforts to ensure sustained compliance and operational excellence.

Non-Technical Skills
Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.

Individual contributor role, with responsibility to lead cross-functional project teams

Education
• Bachelor’s degree in Computer Science or a related scientific or technical discipline (required).
• Master’s degree in Computer Science or a related scientific or technical discipline (preferred).

Experience
• Minimum of 8 years of experience in a GxP-regulated environment, with a focus on Quality Assurance for computerized systems and digital platforms.
• Demonstrated experience in computerized system validation (CSV), including reviewing system requirements, protocols, risk assessments, and technical documentation.
• Experience in data governance, including master data management, metadata standards, and data lifecycle controls.
• Proven ability to collaborate cross-functionally with Automation, IT, Engineering, and Manufacturing teams to ensure systems are implemented and maintained in compliance with 21 CFR Part 11, EU Annex 11, and ALCOA++ principles.
• Experience supporting greenfield or facility start-up projects—including GMP readiness, technical transfer, and inspection preparation—is highly desirable.
• Strong understanding of data integrity requirements, electronic records/electronic signatures (ERES), and global regulatory expectations for GxP systems.
• Prior involvement in regulatory inspections or audits, including preparation, participation, and response development.
• Excellent communication and documentation skills, with the ability to author SOPs, training materials, and technical reports.
• Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law.

This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role.

Requires up to 10% domestic and limited international travel.

The anticipated salary for this position will be $137,000 to $178,900. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentive Program (subject to job level and performance)
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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