James Gunning

About James Gunning

I am a senior Information Technology leader with extensive experience driving digital transformation, modernizing legacy environments, and implementing scalable, compliant solutions across highly regulated industries. My career has centered on leading organizations through complex change—divestitures, acquisitions, and FDA consent decree remediation—while strengthening technology capabilities, quality, and operational resilience.I specialize in modernizing IT infrastructure, deploying cloud-first architectures, improving service delivery, and implementing secure, validated systems that meet stringent regulatory requirements. My background includes deep hands-on experience in IT quality, compliance, computer system validation/assurance, and GxP system support. I bring proven expertise in cloud strategy, cybersecurity, IT service management, and data integrity, supported by expert-level knowledge of 21 CFR Part 11, GAMP, SOX, and FDA expectations.My leadership philosophy is grounded in accountability, transparency, and collaboration. I lead from the front—working closely with teams to remove barriers, cultivate technical excellence, and align IT capabilities with evolving business needs.

Experience

1. Vice President, Global IT and Security

   Xerimis

   Apr 2025 — Present · Moorestown, NJ, US

   As the senior‑most IT executive at Xerimis, I lead the global technology and cybersecurity strategy, ensuring that all systems and platforms are secure, reliable, scalable, cost‑effective, and aligned with organizational goals. I oversee the design, implementation, and governance of the company’s global infrastructure while driving operational excellence and continuous improvement across all technology functions.Key Areas of Responsibility:Strategic Leadership: Develop and communicate the enterprise IT and cybersecurity strategy aligned with corporate objectives and long‑term business growth.Global Architecture & Infrastructure: Lead the design, standardization, and modernization of core infrastructure services across all international sites.Cybersecurity Oversight: Manage global security operations, ensure regulatory compliance, oversee incident response, and drive risk‑mitigation initiatives.Secure Systems Engineering: Architect and implement secure networks, systems, and platforms that support resilient, compliant, and scalable operations.SDLC Governance: Oversee the software development lifecycle, ensuring secure, efficient, and quality‑driven delivery of technology solutions.Financial Management: Direct global IT financial performance, optimize budgets, and ensure strategic, cost‑effective technology investments.Technology Innovation: Evaluate emerging technologies and lead global procurement and implementation efforts to enhance capability, performance, and efficiency.Leadership & Team Development: Coach and develop IT teams, elevating technical expertise, operational maturity, and organizational effectiveness.

Education

• Rowan University

  BS, Computer Science

• Rowan University

  BA/Pre-MBA

• Saint Joseph's University - Erivan K. Haub School of Business

  MBA, Information Systems

• University of Massachusetts Lowell

  MS, Information Technology