Executive Director, IT Quality & Compliance
Listed on 2026-01-14
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IT/Tech
IT Project Manager, IT Consultant
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.
Reports to:
- Reporting to Vice President, IT Global Delivery or Senior Vice President, Enterprise Systems.
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. 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…
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