Site IT/OT & Application Operations Lead

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 the needs of the team, offering guidance or independence as needed, while keeping patient outcomes in mind.
• Stakeholder Management and Alignment Building: Work with different people to build alignment, guide discussions toward common goals, and ensure decisions are aligned with a patient-focused mindset.

Subordinates:

Site end-user and field services support staff as assigned; operational coordination of managed service providers (MSPs) and vendors supporting the IT network, OT network, IT and OT assets, and application support.

Requirements:

• Education
• Bachelor’s degree in Information Technology, Computer Science or a related field a plus
• Experience
• At least 5 years of overall IT experience with a minimum of three  years working in Manufacturing.
• Strong knowledge across several IT disciplines including, Network, Security, Infrastructure, and Manufacturing Systems.
• Good working knowledge of virtual server environments. Experience with the cloud server infrastructure.
• Experience with network monitoring and troubleshooting tools.
• Hands on experience of effective methodologies for Data Back Up and Restore, Data Archive and Retrieval, and Server Image Back up and Restore.
• Experience with starting up and operating a biopharma manufacturing facility is a plus.
• Hands-on experience running incident, problem, and change processes in ServiceNow or a similar ITSM platform, using ITIL service management practices.
• Experience supporting manufacturing and laboratory systems such as MES, LIMS, ERP, EAMS/CMMS, or BMS/EMS in a GMP environment.
• Experience coordinating managed service providers for IT network, OT network, infrastructure assets, or application support against contracted SLAs.
• Technical Skills
• Proficient in MS Office Suite
• Knowledge of Azure, AWS, Cisco Firewalls and Switches
• 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.
• Physical Demands: Initially working on a construction site and ultimately in a biotech manufacturing site in Sanford, NC.
• Working Conditions: Requires up to 10% domestic and limited international travel.
• *Work is 100% on-site.  This is not a hybrid or remote role.
• 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
• 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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• . Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
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• Recruitment & Staffing Agencies
• Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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