drjobs Executive Director, IT Quality & Compliance

Executive Director, IT Quality & Compliance

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Job Location drjobs

Durham, NC - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

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.

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. such as pharmaceutical medical device or biotechnology).
  • Bachelors 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 ones 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. 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 ouraccessibility siteor contact us atLabcorp Accessibility. Formore information about how we collect and store your personal data please see ourPrivacy Statement.


    Required Experience:

    Director

    Employment Type

    Full-Time

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