Associate Director, GXP IT Support

Role Summary

Associate Director, GXP IT Support at Moderna. Lead a global GxP IT support function to ensure reliable, compliant, and secure operations of GxP IT and OT systems across worldwide facilities. Define processes, build team capabilities, and implement ITSM practices aligned with regulatory requirements and security controls.

Responsibilities

• Establish and lead a global GxP IT Support function focused on reliable, compliant, and secure operations for IT and OT systems.
• Define team structure, roles, and operating model with global consistency and collaboration.
• Design and implement ITSM processes for incident, problem, change, and service request management in GxP environments; ensure activities are documented and validated as needed.
• Set and manage SLAs/OLAs to measure performance and drive continuous improvement.
• Develop standardized documentation, runbooks, and support procedures that are audit-ready and compliant.
• Coordinate planned maintenance activities across Digital Core/IT and CMC to minimize disruption and align priorities.
• Collaborate with Cybersecurity and Compliance to ensure GxP systems are supported per security policies; embed access management, patching, and vulnerability remediation into daily operations.
• Partner with Applications and Systems Owners, and stakeholders in Manufacturing and Lab facilities.
• Work with Automation, CMC, and Quality teams to enable smooth transitions of new systems into production with proper documentation and training.
• Ensure all support activities follow SOPs and quality protocols, maintaining audit readiness.
• Provide global operational support to ensure stability, reliability, and performance of GxP IT/OT systems.
• Track and analyze KPIs and service metrics to identify trends and drive process maturity.
• Collaborate with internal IT and engineering teams to manage escalations and resolve cross-functional issues.
• Foster a culture of accountability, compliance, and service excellence with continuous improvement.

Qualifications

• Bachelor‚Äôs degree in Computer Science, Information Systems, Engineering, or related field.
• 10+ years of IT experience, including at least 3 years in a support management or service delivery leadership role.
• Proven experience operating within GxP-regulated environments in biotech, pharmaceutical, or life sciences.
• Strong knowledge of IT Service Management (ITSM) frameworks (ITIL) and experience implementing or maturing ITSM processes.
• Demonstrated ability to build new teams, processes, and support models in complex or regulated settings.
• Experience working cross-functionally with Cybersecurity, Automation, CMC, and Quality teams.
• Deep understanding of SOP-driven environments with commitment to compliance, documentation, and audit readiness.
• Excellent leadership, communication, and stakeholder management skills; ability to influence global teams.
• Strong analytical and problem-solving capabilities with focus on operational excellence and continuous improvement.
• Commitment to continuous learning and staying updated with industry trends, technologies, and best practices.

Skills

• ITSM design and implementation
• GxP compliance and audit readiness
• Cross-functional collaboration
• Security-conscious operations
• Metrics and performance management
• Documentation and SOP adherence

Education

• As listed in Qualifications

Additional Requirements

• Advanced degree or certifications such as ITIL, PMP, CISSP, or CISM (Preferred).
• Familiarity with GxP SaaS or cloud-hosted systems and manufacturing/lab technologies (MES, LIMS, SCADA).
• Understanding of cybersecurity and data integrity frameworks (NIST, ISO 27001, 21 CFR Part 11).
• Experience supporting global IT/OT operations across multiple sites and time zones.
• Ability to implement monitoring, automation, and proactive support models to improve reliability.