Global IT Quality & Compliance Executive Director (GxP/CSA)

Labcorp; Durham (NC); Hybrid; USD 180,000 - 260,000; Full time

Job summary

Labcorp is seeking an Executive Director of IT Quality & Compliance to lead enterprise-wide validation, risk and regulatory programs for global IT systems in a regulated life sciences environment.

The role champions the transition from CSV to CSA, drives governance and AI risk management, and guides a geographically dispersed team while partnering with Legal, Privacy, Security, QA and IT to ensure audit readiness and regulatory alignment.

Qualifications

• Bachelor’s degree in a relevant field.
• 10+ years’ experience in FDA (GXP) regulated industry.
• 5+ years guiding clients at management levels.
• 5+ years leading large IT validation projects.
• 2+ years governance for AI/ML-enabled systems.

Responsibilities

• Lead IT quality, compliance, and validation strategies across global IT.
• Oversee governance, risk assessments, and controls for audit readiness.
• Drive CSV activities and move toward CSA-based approaches.
• Co-own and enhance Software Lifecycle (SLC) framework.
• Define validation for AI, cloud, and analytics with regulatory alignment.
• Provide enterprise-wide regulatory guidance for AI initiatives.
• Maintain IT QMS, policies, SOPs, and templates.
• Support audits, inspections, and RFI responses.
• Establish KPIs for IT compliance, risk, and audit readiness.
• Lead cross-functional collaboration with Legal, Privacy, Security, QA, HR, IT.
• Implement standardized validation tools to improve efficiency.
• Oversee validation standards for data integrity and system reliability.
• Develop a geographically dispersed team (4–10) and manage delivery.

Skills

Leadership

IT governance

Regulatory compliance

CSV/CSA

AI/ML governance

Client engagement

Education

Bachelor’s degree

Job description

Labcorp is seeking an Executive Director of IT Quality & Compliance to lead enterprise-wide validation, risk and regulatory programs for global IT systems in a regulated life sciences environment.

The role champions the transition from CSV to CSA, drives governance and AI risk management, and guides a geographically dispersed team while partnering with Legal, Privacy, Security, QA and IT to ensure audit readiness and regulatory alignment.