Associate Director, GXP IT Support

Role Summary

Associate Director, GXP IT Support responsible for establishing and leading a global GxP IT support function to ensure reliable, compliant, and secure operations of GxP IT and OT systems across worldwide facilities. Partners with Cybersecurity, Digital Core, Automation, CMC, and Quality teams to align with regulatory requirements, internal standards, and security controls. Focuses on process discipline, clear expectations, and continuous improvement within a regulated environment.

Responsibilities

• Establish and lead a global GxP IT Support function focused on providing reliable, compliant, and secure operations for IT and OT systems across worldwide facilities.
• Define the team‚Äôs 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 to ensure effective communication and alignment of priorities across teams.
• Collaborate with Cybersecurity and Compliance to ensure all GxP systems are supported in alignment with security policies, standards, and controls; embed security practices into daily 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.
• Ensure all support activities follow approved SOPs and quality protocols, maintaining audit readiness at all times.
• 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, 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

• 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 industries.
• Strong knowledge of IT Service Management (ITSM) frameworks (e.g., ITIL); experience implementing or maturing ITSM processes.
• Demonstrated ability to build new teams, processes, and support models in a complex or regulated setting.
• 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 with 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
• Regulatory compliance and audit readiness
• Cross-functional collaboration across IT, Cybersecurity, Quality, and Manufacturing
• Leadership and team-building in regulated environments
• Performance metrics and process improvement

Education

• Bachelor‚Äôs degree in Computer Science, Information Systems, Engineering, or related field

Additional Requirements

• Experience with GxP SaaS or cloud-hosted systems and familiarity with manufacturing/lab technologies (MES, LIMS, SCADA) is a plus
• Understanding of cybersecurity and data integrity frameworks (NIST, ISO 27001, 21 CFR Part 11) is beneficial