Executive Director, IT Quality & Compliance

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.