Associate Director, GXP IT Support

Role Summary

We are seeking a GxP IT Support Manager to establish and lead a global support function ensuring reliable, compliant, and secure operations of GxP IT and OT systems across Moderna’s worldwide facilities. The role requires defining processes, building team capabilities, and implementing IT Service Management practices to deliver high-quality support in regulated environments, partnering with Cybersecurity, Digital Core, Automation, CMC, and Quality teams to align with regulatory requirements and security controls.

Responsibilities

• Establish and lead a global GxP IT Support function focused on providing reliable, compliant, and secure operations for IT and OT systems across Moderna’s worldwide facilities.
• Define the team’s structure, roles, and operating model, ensuring clarity of responsibilities, global consistency, and effective collaboration.
• Design and implement IT Service Management (ITSM) processes for incident, problem, change, and service request management in GxP environments, ensuring all GxP IT activities performed are documented and validated/qualified as needed.
• Set and manage service levels (SLAs/OLAs) to measure performance, ensure accountability, and drive continuous improvement across global support operations.
• Develop standardized documentation, runbooks, and support procedures that are audit-ready, repeatable, and aligned with compliance expectations.
• Act as a bridge between Digital Core/IT and CMC, serving as a single point of coordination for planned maintenance activities (e.g., NAC changes, system updates, infrastructure work) to ensure effective communication, minimal disruption, and alignment of priorities across teams.
• Collaborate with Cybersecurity and Compliance to ensure all GxP systems are supported in accordance with enterprise security policies, standards, and controls. Embed security practices such as access management, patching, and vulnerability remediation into daily support operations.
• Partner closely with Applications and Systems Owners, and stakeholders in Manufacturing and Lab facilities.
• Work with Automation, CMC, and Quality teams to ensure smooth transitions of new systems into production, with appropriate documentation, training, and monitoring in place.
• Ensure all support activities follow approved SOPs, work instructions, and quality protocols, maintaining audit readiness at all times.
• Provide global operational support to ensure the stability, reliability, and performance of GxP IT/OT systems.
• Track and analyze KPIs and service metrics to identify trends, optimize performance, and improve process maturity.
• Collaborate with internal IT and engineering teams to manage escalations effectively and resolve cross-functional issues.
• Foster a culture of accountability, compliance, and service excellence within the team, ensuring continuous improvement of the support function.

Qualifications

• Required: Bachelor’s degree in Computer Science, Information Systems, Engineering, or a related field.
• Required: 10+ years of IT experience, including at least 3 years in a support management or service delivery leadership role.
• Required: Proven experience operating within GxP-regulated environments in the biotech, pharmaceutical, or life sciences industries.
• Required: Strong knowledge of IT Service Management (ITSM) frameworks, such as ITIL, and experience implementing or maturing ITSM processes.
• Required: Demonstrated ability to build new teams, processes, and support models in a complex or regulated setting.
• Required: Experience working cross-functionally with Cybersecurity, Automation, CMC, and Quality teams.
• Required: Deep understanding of SOP-driven environments, with a commitment to compliance, documentation, and audit readiness.
• Required: Excellent leadership, communication, and stakeholder management skills, with the ability to influence across global teams.
• Required: Strong analytical and problem-solving capabilities, with a focus on operational excellence and continuous improvement.
• Required: A commitment to continuous learning and professional development, staying updated with the latest industry trends, technologies, and best practices.
• Preferred: Advanced degree or relevant certifications such as ITIL, PMP, CISSP, or CISM.
• Preferred: Familiarity with GxP SaaS or cloud-hosted systems, and exposure to manufacturing and laboratory technologies (MES, LIMS, SCADA).
• Preferred: Understanding of cybersecurity and data integrity frameworks, including NIST, ISO 27001, and 21 CFR Part 11.
• Preferred: Experience supporting or leading global IT/OT operations with multiple sites and time zones.
• Preferred: Proven ability to implement monitoring, automation, and proactive support models that enhance reliability and reduce downtime.
• Preferred: A mindset focused on collaboration, accountability, and operational maturity, with a passion for building scalable, compliant support capabilities.