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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Executive Director of IT Quality & Compliance - **Company:** LabCorp - **Location:** Durham, NC, United States - **Experience:** Experienced - **Contract:** Temporary contract - **Skills:** Artificial Intelligence, Software Applications, Cloud Computing, Data Integrity, IT Management, Systems Development Life Cycle, Software Engineering, System Testing, Information Technology, GXP - **Published:** October 4, 2026 - **Apply:** https://www.themuse.com/jobs/labcorp/executive-director-it-quality-compliance-7254b0 ## About the Role * 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., * 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. ## Description * 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.