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LabCorp

Global life sciences R&D services

Executive Director of IT Quality & Compliance

IT OperationsConfirmed live in the last 24 hours
Full-timeDurham, NC, USANo salary listed

About the Job

Requirements

  • A bachelor's degree is required.
  • At least 10 years of experience in an FDA GxP-regulated industry such as pharmaceutical, medical device, or biotechnology.
  • At least 10 years of experience leading or managing teams, developing strategies, and executing projects.
  • At least 5 years of experience partnering with or guiding clients at management levels.
  • At least 5 years of experience leading large IT validation projects.
  • At least 2 years of experience providing governance or delivery oversight for AI/ML-enabled systems, preferably in regulated life sciences.
  • Demonstrated experience leading an organizational shift from Computer System Validation (CSV) to Computer Software Assurance (CSA), including enterprise rollout of policies and procedures and at least one end-to-end implementation in a regulated GxP environment.
  • Strong expertise in validation methodologies, including Software Development Life Cycle (SDLC), within IT environments.
  • Knowledge of GxP regulations in pharmaceuticals and drug development.
  • Firsthand experience with AI risk management and awareness of emerging AI regulations.
  • Financial and budget management experience.
  • Proficiency in Microsoft Office tools.
  • Fluency in written and spoken English.
  • Ability to work flexibly across time zones and outside standard business hours as needed.

Responsibilities

  • Lead the development and execution of IT quality, compliance, and validation strategies aligned with enterprise risk and global regulatory requirements, including GxP, SOX, and GDPR.
  • Oversee IT governance, risk assessments, and internal controls to maintain audit readiness and regulatory compliance across global operations.
  • Drive computer system validation activities, including initial validation, change control, and periodic reviews, while evolving toward a risk-based Computer Software Assurance approach focused on critical thinking.
  • Co-own and enhance the Software Lifecycle framework and implement harmonized, risk-based validation methodologies across IT systems.
  • Define and tailor validation approaches for emerging technologies, including AI, cloud, and advanced analytics, to ensure scalability and regulatory alignment.
  • Provide enterprise-wide governance and regulatory guidance for AI initiatives, including model lifecycle controls and responsible AI practices from design through operations.
  • Maintain and continuously improve the IT Quality Management System, including policies, standard operating procedures, work instructions, and templates.
  • Support internal and external audits, regulatory inspections, and requests for information; represent IT in audit and regulatory engagements.
  • Establish, track, and report key performance indicators related to IT compliance, risk, validation, and audit readiness.
  • Govern IT training processes, including the IT Training Matrix and delivery of compliance and Software Lifecycle training programs.
  • Collaborate with Legal, Privacy, Security, Quality Assurance, Human Resources, Corporate Audit, and IT teams to ensure enterprise-wide compliance.
  • Implement standardized validation tools and processes to improve efficiency, reduce compliance costs, and protect company assets.
  • Oversee validation standards and testing methodologies to ensure system quality, data integrity, infrastructure reliability, and subject safety.
  • Lead and develop a geographically dispersed team of 4–10, managing performance, engagement, budget, and delivery of strategic initiatives.
  • Drive talent development, coaching, and succession planning to build a high-performing and future-ready organization.

Desired Qualifications

  • At least 15 years of experience in an FDA GxP-regulated industry such as pharmaceutical, medical device, or biotechnology.
  • Industry-related certifications such as PMP, CQE, or CQM.
  • An MS or MBA.
  • Experience providing governance or delivery oversight for AI/ML-enabled systems in regulated life sciences.

About the Company

LabCorp

Global life sciences R&D services

Labcorp provides global life sciences and healthcare R&D services, supporting pharma, biotech, and crop protection clients with testing, safety assessments, and regulatory submissions. It conducts studies ranging from basic physicochemical tests to complex inhalation toxicology and uses specialized facilities to evaluate inhaled substances and ensure regulatory compliance. Its global presence and integrated suite of services enable clients to move projects from early development to product approval within one organization. Labcorp aims to help clients bring safe, effective products to market efficiently, advancing human health and scientific research.

Company size
10,001+
Company stage
IPO
Headquarters
Burlington, VT
Founded
1976

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