Executive Director, IT Quality & Compliance

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 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.

Executive Director of IT Quality & Compliance, 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.
• Industry related certifications such as PMP, CQE, or CQM
• MS/MBA

Additional Job Standards

• Demonstrated experience leading an organizational shift from Computer System Validation (CSV) to Computer Software Assurance (CSA), including successful enterprise rollout of policies, procedures, and at least one end‑to‑end implementation in a regulated (GxP) environment.
• Strong expertise in validation methodologies (SDLC) within IT environments
• Solid knowledge of GxP regulations in pharma and drug development
• Firsthand experience with AI risk management and awareness of emerging AI regulations
• Financial and budget management experience
• Creative analytical person able to balance technical and business needs.
• Excellent people skills with ability to influence and build trust across all levels.
• Proven leadership ability to build, develop, and mentor high-performing teams.
• Strong program and project management skills across multiple initiatives
• Clear and effective written and verbal communication skills
• Customer-focused with strong conflict resolution capabilities
• Strong problem-solving and decision-making skills in demanding environments
• Highly organized with the ability to prioritize and manage multiple tasks.
• Adaptable and responsive to changing business needs and priorities.
• Effective time management for self and team
• Proficiency in Microsoft Office tools
• Fluent in English (written and spoken)
• Comfortable working in a hybrid/remote office environment
• Flexible working across time zones and outside standard business hours as needed.

Get to know Labcorp

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations.

Here, you can join our more than 60,000 employees, serving clients in more than one hundred countries, as we work together to make a real impact on people’s lives.

Benefits

Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan. For more detailed information, pleaseclick here.

Labcorp Is Proud To Be An Equal Opportunity Employer

Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

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