Site IT/OT & Application Operations Lead
Kyowa Kirin North America · Sanford, NC · onsite
Kyowa Kirin is a global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation, dedicated to discovering and advancing treatments for diseases in which unmet need is greatest. Based in Japan with worldwide operations, we work across the continuum from drug discovery to commercialization, guided by our commitment to patients and their families.
Our research teams, located in California and around the world, are focused on developing the next generation of antibody, cell, and gene therapies, with particular emphasis on bone and mineral disorders, hemato-oncology, and rare diseases. We accelerate development through collaborations with industry, academia, patients, and healthcare providers, and since 2018 we have introduced four new therapies serving patients with progressive illnesses often in need of new therapeutic alternatives.
Our culture is grounded in our values: Commitment to Life, Integrity, Innovation, and Teamwork/Wa, and brought to life through the Kabegoe Principles, which define the behaviors and actions that guide how we work together to deliver meaningful impact for patients.
We’re proud of the progress we’ve made and mindful of the countless individuals still waiting for their own breakthroughs. A commitment to making people smile unites our efforts. Learn more at www.kkna.kyowakirin.com.
Summary:
As the Manufacturing Site IT/OT & Application Operations Lead, your role will be to serve as the operational owner for IT OT, and site application services. You will run and sustain the operational state of site systems once they are built and validated, so that Manufacturing, QC, and Quality can rely on a stable, compliant, and well-supported technology. This role leads incident, problem, and change coordination, service level management, operational GMP controls, and ServiceNow-based support processes across site infrastructure, OT interfaces, and GxP applications such as MES, LIMS, ERP site functions, You will partner with the Plant IT Infrastructure Lead to plan and execute the build-to-run transition as systems go live, and serve as the site coordination point for managed service providers (MSPs) and vendors supporting the IT network, OT network, selected IT and OT assets, and application support, ensuring issues are resolved in line with agreed service levels. The role coordinates operations but does not hold System Administrator or System Owner rights for GxP applications, preserving segregation of duties. This role requires strong IT service operations experience, from support model design to day-to-day execution, in a Life Sciences Manufacturing environment.
As a leader, you will embody compassionate, people-centric leadership to guide and support our team. You will collaborate closely with others, fostering a collaborative, inclusive, and supportive environment while driving team development. Your work will reflect the organization’s values and integrity in all your actions. Utilizing situational leadership and emotional intelligence, you will align diverse viewpoints, manage stakeholders, and make empathetic decisions to address individual and team needs effectively. You will also be results-oriented, ensuring that your team not only adapts to challenges but also delivers measurable outcomes that align with business objectives. Additionally, you will help teams navigate through change and uncertainty with resilience and clarity, enabling them to adapt to fast-evolving, rapidly scaling environments and meet new challenges in the biotech industry with a patient-focused mindset.
Essential Functions:
Technical Skills, Knowledge, and Experience
• Act as the single point of contact and accountable operations leader for site IT, OT support coordination, and site application services for manufacturing, lab, and office users.
• Define and run the site support model, including run-books, support hours, on-call rotations, and escalation paths to application analysts, the Plant IT Infrastructure Lead, and regional product teams.
• Partner with the Plant IT Infrastructure Lead and project teams to plan and execute build-to-run handover, phasing application operations in as each system reaches its validated state.
• Own triage, routing, escalation, and major incident coordination for site infrastructure, OT interfaces, and site applications, with consistent GxP incident flagging.
• Lead problem management and root cause analysis for recurring issues, and drive permanent fixes with technical owners.
• Track and report service levels for infrastructure, OT support, and site applications, and produce monthly operational dashboards for site leadership.
• Define and maintain site-level MSP operating procedures, including ServiceNow assignment groups, escalation matrices, site access and escort requirements, and handoffs between site staff, MSPs, Application Analysts, and Engineering / Automation.
• Coordinate MSP participation in major incidents, root cause analysis, and problem resolution, and track MSP corrective actions through to closure.
• Monitor and report MSP and vendor SLA performance, run monthly operational service reviews, manage service credits, and escalate performance gaps to the Site ICT Director and global vendor management.
• Maintain site catalog items, assignment groups, knowledge articles, and support workflows in ServiceNow in alignment with global ITSM standards, and use ServiceNow data to reduce repeat incidents and improve first-time resolution.
• Provide and coordinate technical support and troubleshooting assistance to end-users, including shop floor and laboratory users.
• Work with the various system owners to maintain the computer systems inventory and the support assignments for each system.
• Stay up to date with the latest technology trends and advancements in the pharma and manufacturing industry.
GMP and Compliance Responsibilities
• Operate one unified IT/OT/application change process aligned to site QA change control, confirming QA approval before GxP changes are implemented, including changes performed by MSPs and vendors.
• Ensure MSP and vendor activities on GxP systems and networks follow site procedures, change control, access management, and documentation requirements, and support supplier oversight and periodic supplier assessments with IT Quality.
• Coordinate application downtime procedures, business continuity, and recovery exercises with system users and technical owners.
• Ensure compliance with regulatory requirements and BI / external standards (EHS, Corporate procedures, GxP, 21 CFR Part 11, EU GMP Annex 11, GAMP 5).
• Provide operational evidence and subject matter experts during audits and regulatory inspections.
Leadership
• Results-Oriented: Lead teams by setting clear, measurable goals and ensuring accountability for achieving key objectives. Align resources effectively, remove obstacles, and maintain focus on delivering high-quality results within set timelines.
• Empathetic Communication: Listen carefully, give helpful feedback, and handle conflicts with care.
• Team Development: Mentor and guide team members, create growth plans when applicable, support ongoing learning, and develop team members with a patient-focused mindset.
• Inclusive Leadership: Build a diverse, respectful environment where everyone feels valued and supported.
• Supportive Environment: Encourage a positive workplace, celebrate achievements, and promote work-life balance.
• Collaboration: Lead by example, promote teamwork and respect, and ensure your actions reflect the organization’s values.
• Emotional Intelligence: Manage emotions thoughtfully, make empathetic decisions with a patient-focused mindset, and stay calm under pressure.
• Change Management: Help teams navigate change with clear communication and flexibility.
• Situational Leadership: Adapt your leadership style to meet t