Executive Director, IT Quality & Compliance

Labcorp is hiring an Executive Director, IT Quality and Compliance. This is a strategic leadership role responsible for driving enterprise-wide IT compliance, governance, and quality assurance across the Diagnostics and BLS business units. This role ensures IT systems and processes meet global regulatory requirements and internal standards, while fostering a culture of continuous improvement, risk awareness, and operational excellence.

This hybrid position offers a balanced schedule of a minimum of three in-office days at an assigned location to be either Burlington or Durham, NC, supporting both collaboration and flexibility.

Key Responsibilities:

• Lead the development and execution of IT quality and compliance strategies aligned with enterprise risk and regulatory requirements.
• Oversee IT governance, risk assessments, and internal controls to ensure compliance with GxP, SOX, GDPR, and related regulations.
• Manage computer system validation activities, including initial validation, change control, and periodic reviews.
• Support internal and external audits, regulatory inspections, and RFI responses across global regions.
• Maintain and enhance the IT Quality Management System (QMS), including controlled documents such as policies, SOPs, work instructions, and templates.
• Govern the IT training process, including the IT Training Matrix and delivery of compliance training programs.
• Co-own and manage the Software Life Cycle (SLC) methodology; provide training on SLC processes and deliverables.
• Define and report on KPIs related to IT compliance, risk, and audit readiness.
• Collaborate with Legal, Privacy, Security, QA, HR, and IT teams to ensure cross-functional compliance.
• Lead a geographically dispersed team of 4-10 direct reports; manage budget, allocation, and project delivery.

• Reporting to Vice President, IT Global Delivery or Senior Vice President, Enterprise Systems.

• Lead the development of a risk-based validation methodology and a harmonized Software Life Cycle (SLC) framework across IT systems.
• Define and tailor validation approaches for emerging technologies such as AI, cloud platforms, and advanced analytics, ensuring scalability and regulatory compliance.
• Implement standardized tools for computer systems validation to improve efficiency, reduce compliance costs, and protect company assets.
• Oversee the review and alignment of LDD testing methodologies, procedures, and practices with validation standards.
• Ensure regulatory controls for LDD systems to maintain application quality, infrastructure reliability, data integrity, and subject safety.
• Deliver technology solutions, standards, and processes that support departmental objectives and compliance goals.
• Develop and manage validation models for IT initiatives, ensuring consistency and adherence to regulatory expectations.
• Collaborate with Corporate Audit, Business Unit QA, and IT Security to leverage supplier data and continuously improve validation and SLC practices.
• Lead performance management and engagement for a geographically dispersed team, fostering collaboration and high performance.
• Drive succession planning, identifying and developing high-potential talent to support long-term organizational needs.
• Coach direct reports in building development plans that strengthen leadership abilities and align with succession goals.
• Oversee compliance training for IT staff, including governance of tools & methods and maintenance of the IT Training Matrix.
• Represent IT in regulatory and client audits, providing documentation and evidence related to validation, IT processes, disaster recovery, security, and training.

• 10+ years' experience in an FDA (GXP) regulated industry (i.e. such as pharmaceutical, medical device, or biotechnology).
• Bachelor's Degree required (ex. science based, operations research, technology, etc.)
• 10+ years' experience leading/managing teams, developing strategies, execution of projects, and 5+ years partnering/guiding clients at management levels.
• 5+ years leading large IT validation projects.

• Industry related certifications preferred (e.g. PMP, CQE, CQM, etc.)
• MS/MBA preferred.
• Current or previous Labcorp experience is preferred.

• Expert in various validation methodologies (SDLC), and their implementation in an IT organization.
• Knowledgeable of regulatory compliance requirements in the pharmaceutical and drug development industry (GXPs).
• Financial analysis and management.
• Creative approach to resolving technical issues, and balancing IT and business needs.
• Strong interpersonal skills and ability to command respect of others.
• Ability to interact with all levels within the organization.
• Proven ability to build strong teams, provide leadership and training to others, and develop professional level staff.
• Program & Project Management experience - ability to plan, organize, and execute work across multiple initiatives.
• Communication: Strong verbal and written communication skills for effective interactions with employees, customers, and higher management.
• Customer Service: Commitment to providing excellent customer service and resolving conflicts or complaints gracefully.
• Problem-Solving: Ability to quickly find solutions to problems as they arise, often in a high-pressure environment.
• Decision-Making: Confidence and ability to make decisions that affect the store operations and staff.
• Organizational Skills: Proficiency in managing multiple tasks, prioritizing duties, and maintaining organization in a dynamic environment.
• Adaptability: Being able to adapt to changes in the market, customer preferences, and business strategies.
• Time Management: Efficiently managing one's own time and the time of others to ensure operational efficiencies.
• Speaking English required.
• Writing/Reading English required.
• Competent in the use of Microsoft Office.

• General office environment/Remote (Hybrid).
• Flexibility in schedule to travel as necessary during non-business hours.
• Flexibility in schedule to work across time zones as necessary during non-business hours.
• Travel requirements 10% of time.
• 100% of the above that requires overnight stay.
• Travel is primarily Local, domestic regional & International Travel.