Executive Director, IT Quality & Compliance
Labcorp
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 to join our team in 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 If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement. #J-18808-Ljbffr Labcorp$220k - $245k
Summary of Responsibilities Provides executive leadership for Quality Assurance (QA) and Regulatory Compliance within the Clinical Pharmacology Services (CPS) business unit, ensuring a robust, risk-based, and inspection-ready quality management system aligned with global...SuggestedFull timePart timeFlexible hours- ...health and improving lives.Labcorp is seeking a remote Executive Director, Digital Systems IT Product Management to join our team!Location: Durham, NCApplicants... ...all digital platform systems offerings.Ensure global compliance with industry standards and regulations including HIPPA...SuggestedFull timeTemporary workCasual workInternshipWork at officeRemote workMonday to FridayFlexible hoursDay shift3 days per week
$725 per month
...Executive Director - Senior Living Community Supporting Assisted Living and Memory Care Residents... ...financial performance, and regulatory compliance. Creates and executes the business... ...community culture that provides high quality resident experiences and care and engages...SuggestedHourly payFull timeTemporary workPart timeLocal areaFlexible hoursShift workNight shiftAfternoon shift$88.6k - $246.6k
Job Overview Provide strategic quality leadership and oversight across assigned Quality Assurance... ..., and oversight of quality systems and compliance programs. Lead and coordinate QA... ...valuable, candidates with a predominantly IT Quality Assurance background and limited...SuggestedFull timePart timeWork at officeImmediate startWorldwide- ...experience to ensure compliance with pharmaceutical, biotechnology... ...client facilities Quality Management System (QMS... ...Management Systems as it pertains to quality... ...to ensure successful execution of the Quality... ...and Customer Services Director to support normal client...Suggested
- ...environment , along with related enterprise IT systems supporting both organizations.... ..., ensuring reliability, security, compliance, operational efficiency, and alignment with... ...RESPONSIBILITIES: Establishes and executes the strategic direction for all information...Contract workWork at officeLocal area
- ...strategic oversight to ensure compliance with privacy, information... ...for PHI and genomic data.Data Quality, Interoperability &... ...Partner with clinicians, lab directors, IT, compliance, and R&D teams to... ...leadership with the ability to execute governance strategies.Effective...Full timeTemporary workCasual workInternshipWork at officeMonday to FridayFlexible hoursDay shift3 days per week
- ...Sr. Director, Quality Control and Analytical Development The Sr. Director, Quality Control... ...prioritizes deliverables to meet site and compliance objectives Overseeing all... ...ability to develop, communicate, and execute plans and strategies with a wide range...Flexible hoursShift work
$109.86k - $191.06k
...Associate Director, Quality AssuranceWork Arrangement: On-SiteLocation: Durham, NC, US, 27710School of Medicine Established in 1930, Duke... ...the Director, Quality and plays a critical role in supporting compliance, operational excellence, and continuous improvement across...Work experience placementWork at office- ...improving lives.Labcorp is seeking an Executive Director, AI Transformation, Office of the CAIO... ...development, and role evolution. Ensure compliance with legal, regulatory, privacy,... ...Clinical Trials and BioPharma operations, or Quality, Compliance, and Regulatory operations...Full timeTemporary workCasual workInternshipWork at officeFlexible hours
$138.6k - $257.4k
...Location: Morrisville, NC Join Novartis as our QA Compliance and Systems Head and help shape the quality foundation that enables the delivery of medicines to... ...and their families takes more than innovative science. It takes a community of smart, passionate people like...Worldwide- ...For more information, visit . JOB SUMMARY: The Executive Director, Clinical Development & Medical Affairs is... ...and other meetings Collaborate with Regulatory & Quality to ensure proactive compliance with appropriate regulations Provide all personnel...Temporary workLocal areaRemote workVisa sponsorship
$173.2k - $272.6k
Job DescriptionJob SummaryThe QMS Global Quality Compliance Director reports into the Associate Vice President, Global QMS and is a senior quality... ...and compliance role responsible for driving strategy, execution, and oversight of key quality compliance activities across...Full timeFor contractorsLocal areaFlexible hours- ...deliver. What is the role? The Senior Director of Quality Assurance is responsible for development... ...and have accountability for execution of all strategic imperatives. The role... ...and resolution of product quality and compliance issues seen at approved service providers...Work at office
- ...company. This hands-on leader will move between strategy and execution, overseeing a small team, processes, and regulatory... ...partner with leadership to scale the business while maintaining quality and strong compliance with FDA requirements. #J-18808-Ljbffr Jobleads-US
- ...#discoverbetter. What is the role? The Senior Director of Quality Assurance is responsible for... ...responsibilities and have accountability for execution of all strategic imperatives. The role... ...and resolution of product quality and compliance issues seen at approved service...Work at office
$220k - $245k
Fortrea in Durham is seeking an executive leader for Quality Assurance and Regulatory Compliance in the Clinical Pharmacology Services business unit. This role requires 15+ years of experience and expertise in GCP and GMP, with a focus on clinical pharmacology. The successful...- Title: Director/Senior Director, R&D Quality Location: Remote (with periodic visits to TG headquarters in Morrisville... ...(GCP) activities to ensure compliance with FDA, EMA, ICH, other... ...audit program. Design and lead the execution of GCP inspection readiness projects...Temporary workRemote work
- ...patients across 80 countries. What is the role? The Senior Director of Quality Assurance is responsible for developing and maintaining... ...include investigations and resolution of product quality and compliance issues at approved service providers, oversight of clinical...Work at office
- Job DescriptionJob Summary The QMS Global Quality Compliance Director reports into the Associate Vice President, Global QMS and is a senior quality... ...and compliance role responsible for driving strategy, execution, and oversight of key quality compliance activities across...Full time
- Director, Regulatory Affairs & Quality At ACHC we hire only the best. As a non-profit company with... ...Medicare & Medicaid Services (CMS). It is essential that this... ...Organizational Alignment Advises executive leadership on emerging compliance risks, evolving regulatory trends...Work experience placementWork at officeRemote workRelocation package2 days per week
- The Quality Control Manager (QCM) is responsible for developing, implementing, and maintaining the contractor's Quality Control Program... ...maintain the site‑specific Quality Control Program (QCP) in compliance with FAR Clauses 52.246‑2, 52.246‑4, 52.246‑6, and 52.246‑12...Contract workFor contractors
- ...services. Your determination to deliver quality and accuracy will improve health... ...in the future. Job Summary The Executive Medical Director provides advanced medical and strategic... ...pharmacovigilance, medical monitoring, quality and compliance, process improvement, training and...Full timeWork at office
$138.6k - $257.4k
...pivotal role in ensuring patients receive high-quality medicines that meet the highest standards of safety, compliance, and reliability. This is an opportunity to lead... ...their families takes more than innovative science. It takes a community of smart, passionate people...- ...Objectives: The Site US Senior GMDP Quality Assurance Manager will... ...operations, ensure continued compliance with regulatory Good Manufacturing... ...review/approval, executed batch record review, QA oversight... ...business, or client‑related risks IT literate, including Microsoft...Full timeTemporary workFlexible hours
- Labcorp seeks an Executive Director of Digital Systems IT Product Management to lead the enterprise digital platform systems portfolio, shaping strategy and coordinating across engineering, UX, marketing, and business domains. This role drives AI-enabled product management...Remote job
- ...experienced and vision-driven Associate Director/Director, Quality Assurance to serve as the Site... ...phase appropriate Quality oversight and compliance with CGMP regulations, internal standards... ...and support staff to ensure executed batch records and associated documents...Local area
- Headwater Science in Durham, NC seeks a talented QA Program Manager to lead Regulatory Affairs and Quality Assurance, building and maintaining quality systems and ensuring compliance with regulatory standards. You will oversee GDP, QMS, SOPs, and GCP/GPP processes;...
- ...Executive Director, Clinical Platforms & Product Development About the Company Well-established... ...delivery, strong governance, and high-quality execution. They will also be accountable... ...Manager Title Vice President, Clinical IT Platforms Functions Product...Contract work
- ...improving health and improving lives.Labcorp is seeking an Executive Director, Strategic Enablers, Frontier Partnerships and R&D to join our... ...industries supporting solutions involving PII, PHI, compliance, validation, and audit requirements.5 or more years of experience...Full timeTemporary workCasual workInternshipFlexible hours
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