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.
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, please click here.
