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Executive Director, IT Quality & Compliance

Labcorp

Labcorp seeks an Executive Director of IT Quality & Compliance to lead IT governance, validation strategies, and regulatory compliance across global operations. The role involves overseeing computer system validation, AI governance, quality management systems, and a geographically dispersed team in a hybrid Durham, NC position.

Responsibilities

  • Lead IT quality, compliance, and validation strategies aligned with regulatory requirements (GxP, SOX, GDPR)
  • Oversee computer system validation activities, change control, and evolving risk-based approaches
  • Establish governance and guidance for AI initiatives including model lifecycle controls
  • Maintain and improve IT Quality Management System including policies, SOPs, and training programs
  • Lead and develop geographically dispersed team (4-10), managing performance and strategic delivery

Requirements

  • Bachelor's degree required
  • 10+ years in FDA-regulated industry (pharma, medical device, biotech)
  • 10+ years leading teams and executing strategic projects
  • 5+ years IT validation project leadership in regulated environments
  • 2+ years AI/ML governance or delivery oversight in life sciences
  • Experience transitioning from CSV to CSA methodology with enterprise implementation
  • Strong knowledge of GxP regulations and SDLC validation methodologies
Vacancy posted 6 days ago
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