Kyowa Kirin, Inc.- U.S.
Quality Systems & Compliance, Digital Lead
Kyowa Kirin, Inc.- U.S., Sanford, North Carolina, United States, 27330
Overview
Quality Systems & Compliance, Digital Lead – Sanford, NC Kyowa Kirin is a global specialty pharmaceutical company applying state-of-the-art biotechnologies to discover and deliver novel medicines across four disease areas. In North America, the company is 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 North American monoclonal antibody drug substance manufacturing facility in Sanford, NC. This role starts in a greenfield environment and 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 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. You will also 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 collaborate with others to create a supportive and inclusive environment, act in line with the organization’s values, and deliver results while adapting to a fast-paced environment with patients in mind. This position reports to the Sr. Manager, Quality Systems & Compliance. Responsibilities
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 regulatory requirements and maintain inspection readiness across all GxP areas. Lead cross-functional collaboration to design and execute automation strategies that accelerate digital transformation and enhance operational efficiency in manufacturing, laboratory, engineering, warehouse, and quality operations. Design and optimize automated workflows to meet business objectives, ensure global regulatory compliance, and optimize performance across GxP operations. Establish and enforce the site’s data governance framework with master data management protocols, metadata standards, and data lifecycle controls for consistent, compliant data across digital platforms. Monitor and communicate progress on Quality Systems goals by delivering performance reports and presenting insights to Site Leadership and stakeholders. Shape Quality IT strategies and system options during early-stage site activities to ensure electronic systems meet compliance and operational needs. Ensure site-wide compliance with data integrity standards (e.g., ALCOA++, 21 CFR Part 11) by leading design, implementation, and integration of GxP electronic systems with Global and Regional teams. Apply risk management methodologies to document risk-based decisions with rationale and data to support audit readiness. Partner with site functions to achieve production targets compliantly across Manufacturing, Warehouse, Engineering, and Laboratory areas. Influence QA qualification strategy for computerized systems and automation by guiding cross-functional teams and ensuring systems are validated and ready for commissioning, in alignment with regulatory and business objectives. Serve as a core member of the site-based inspection management team, coordinating GxP refresher trainings and conducting walkthroughs to proactively identify risks and maintain inspection readiness. Deliver site-wide onboarding, training, and mentoring for employees and contractors in accordance with staffing plans and regulatory standards. Define and track key performance indicators with Global and Regional teams and lead site management reviews to drive continuous improvement. Lead inspection readiness activities across all GxP areas by coordinating cross-functional efforts to close gaps and fulfill audit action plans. Qualifications
Education • Bachelor’s degree in Computer Science or related field (required). • Master’s degree in Computer Science or related field (preferred). Experience • Minimum of 8 years in a GxP-regulated environment with a focus on Quality Assurance for computerized systems and digital platforms. • Experience in computerized system validation (CSV) including reviewing requirements, protocols, risk assessments, and documentation. • Experience in data governance, master data management, metadata standards, and data lifecycle controls. • Ability to collaborate cross-functionally with Automation, IT, Engineering, and Manufacturing teams to ensure 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, ERES, and global regulatory expectations for GxP systems. • Involvement in regulatory inspections or audits, including preparation, participation, and response development. • Excellent communication and documentation skills for SOPs, training materials, and technical reports. • Ability to work in office and regulated manufacturing environments, including construction/start-up phases, with PPE as required. Additional • This position is on-site in Sanford, NC. Domestic and limited international travel up to 10% may be required. Compensation & Benefits The anticipated salary is $137,000 to $178,900, with actual offers varying based on experience and other factors. Benefits include: 401K with company matching; discretionary profit sharing; annual bonus; PTO/holiday schedule; healthcare; well-being programs; long-term incentive program; life and disability insurance; pet insurance; tuition assistance; and employee referral rewards. Benefits details apply to US hires; international offers follow local market practices. Equal Opportunity Kyowa Kirin North America is an equal opportunity employer. We do not discriminate on any protected status, and we comply with applicable equal employment opportunity laws. Please note: This posting does not include agency resumes unless directly contacted by Kyowa Kirin Talent Acquisition.
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Quality Systems & Compliance, Digital Lead – Sanford, NC Kyowa Kirin is a global specialty pharmaceutical company applying state-of-the-art biotechnologies to discover and deliver novel medicines across four disease areas. In North America, the company is 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 North American monoclonal antibody drug substance manufacturing facility in Sanford, NC. This role starts in a greenfield environment and 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 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. You will also 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 collaborate with others to create a supportive and inclusive environment, act in line with the organization’s values, and deliver results while adapting to a fast-paced environment with patients in mind. This position reports to the Sr. Manager, Quality Systems & Compliance. Responsibilities
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 regulatory requirements and maintain inspection readiness across all GxP areas. Lead cross-functional collaboration to design and execute automation strategies that accelerate digital transformation and enhance operational efficiency in manufacturing, laboratory, engineering, warehouse, and quality operations. Design and optimize automated workflows to meet business objectives, ensure global regulatory compliance, and optimize performance across GxP operations. Establish and enforce the site’s data governance framework with master data management protocols, metadata standards, and data lifecycle controls for consistent, compliant data across digital platforms. Monitor and communicate progress on Quality Systems goals by delivering performance reports and presenting insights to Site Leadership and stakeholders. Shape Quality IT strategies and system options during early-stage site activities to ensure electronic systems meet compliance and operational needs. Ensure site-wide compliance with data integrity standards (e.g., ALCOA++, 21 CFR Part 11) by leading design, implementation, and integration of GxP electronic systems with Global and Regional teams. Apply risk management methodologies to document risk-based decisions with rationale and data to support audit readiness. Partner with site functions to achieve production targets compliantly across Manufacturing, Warehouse, Engineering, and Laboratory areas. Influence QA qualification strategy for computerized systems and automation by guiding cross-functional teams and ensuring systems are validated and ready for commissioning, in alignment with regulatory and business objectives. Serve as a core member of the site-based inspection management team, coordinating GxP refresher trainings and conducting walkthroughs to proactively identify risks and maintain inspection readiness. Deliver site-wide onboarding, training, and mentoring for employees and contractors in accordance with staffing plans and regulatory standards. Define and track key performance indicators with Global and Regional teams and lead site management reviews to drive continuous improvement. Lead inspection readiness activities across all GxP areas by coordinating cross-functional efforts to close gaps and fulfill audit action plans. Qualifications
Education • Bachelor’s degree in Computer Science or related field (required). • Master’s degree in Computer Science or related field (preferred). Experience • Minimum of 8 years in a GxP-regulated environment with a focus on Quality Assurance for computerized systems and digital platforms. • Experience in computerized system validation (CSV) including reviewing requirements, protocols, risk assessments, and documentation. • Experience in data governance, master data management, metadata standards, and data lifecycle controls. • Ability to collaborate cross-functionally with Automation, IT, Engineering, and Manufacturing teams to ensure 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, ERES, and global regulatory expectations for GxP systems. • Involvement in regulatory inspections or audits, including preparation, participation, and response development. • Excellent communication and documentation skills for SOPs, training materials, and technical reports. • Ability to work in office and regulated manufacturing environments, including construction/start-up phases, with PPE as required. Additional • This position is on-site in Sanford, NC. Domestic and limited international travel up to 10% may be required. Compensation & Benefits The anticipated salary is $137,000 to $178,900, with actual offers varying based on experience and other factors. Benefits include: 401K with company matching; discretionary profit sharing; annual bonus; PTO/holiday schedule; healthcare; well-being programs; long-term incentive program; life and disability insurance; pet insurance; tuition assistance; and employee referral rewards. Benefits details apply to US hires; international offers follow local market practices. Equal Opportunity Kyowa Kirin North America is an equal opportunity employer. We do not discriminate on any protected status, and we comply with applicable equal employment opportunity laws. Please note: This posting does not include agency resumes unless directly contacted by Kyowa Kirin Talent Acquisition.
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