Executive Director, IT Quality & Compliance

Executive Director, It Quality And 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 410 direct reports; manage budget, allocation, and project delivery.

Duties & Responsibilities:

• 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.

Minimum Education and Experience Required:

• 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.

Preferred Qualifications:

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

Skills and Competencies:

• 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.

Working Conditions:

• 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.

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. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only.

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.

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