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Executive Director, IT Quality & Compliance

Laboratory Corp of America

Durham NCStaff
Sign in to applyVerified 1h ago
Location
Durham NC
Work model
On-Site
Level
Staff
Posted
18h ago

About this role

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world’s most important health challenges. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career and make a real impact on people’s health around the world. Together, we’re improving health and improving lives. Labcorp is seeking an Executive Director of IT Quality & Compliance to join our team in Durham, NC . Work Schedule Hybrid (minimum 3 days a week on-site), standard business hours Monday - Friday. Willingness to travel (~10%), including occasional domestic and international overnight travel.

Job Responsibilities

Lead the development and execution of IT quality, compliance, and validation strategies aligned with enterprise risk and global regulatory requirements (GxP, SOX, GDPR). Oversee IT governance, risk assessments, and internal controls to ensure audit readiness and regulatory compliance across global operations. Drive computer system validation (CSV) activities including initial validation, change control, and periodic reviews, evolving toward a risk-based CSA approach focused on critical thinking. Co-own and enhance the Software Lifecycle (SLC) framework and implement harmonized, risk-based validation methodologies across IT systems. Define and tailor validation approaches for emerging technologies (AI, cloud, advanced analytics) ensuring 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 (QMS), including policies, SOPs, work instructions, and templates. Support internal/external audits, regulatory inspections, and RFI responses; represent IT in audit and regulatory engagements. Establish, track, and report KPIs related to IT compliance, risk, validation, and audit readiness. Govern IT training processes, including the IT Training Matrix and delivery of compliance and SLC training programs. Collaborate cross-functionally with Legal, Privacy, Security, QA, HR, 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 (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.

Minimum Qualifications

Bachelor’s degree 10 or more years’ experience in an FDA (GXP) regulated industry such as pharmaceutical, medical device, or biotechnology. 10 or more years’ experience leading/managing teams, developing strategies, execution of projects. 5 or more years’ partnering/guiding clients at management levels. 5 or more years leading large IT validation projects. 2 or more years of experience providing governance or delivery oversight for AI/ML‑enabled systems preferably in regulated life sciences.

Preferred Qualifications

15 or more years’ experience in an FDA (GXP) regulated industry such as pharmaceutical, medical device, or biotechnology.

Executive Director, IT Quality & Compliance at Laboratory Corp of America, Durham NC | Yoinka