Executive Director, Head of Digital Quality

Role Overview

• Lead the digital quality function with full accountability for strategy, execution, and performance.
• Build and direct a diverse digital quality team; drive cross-functional collaboration with IT, manufacturing, regulatory, and supply chain
• Champion digital transformation (automation, AI/ML, advanced analytics) across all GMP quality activities, ensuring harmonization and standardization including SaMD, eQMS, and data platforms.
• Partner with senior executive leadership on strategic issues with Gilead-wide impact.
• Build collaborative relationships across functions and with external partners to drive innovation and compliance.
• Oversee, Develop and maintain the Quality Management System (QMS) for digital health products and GxP computerized systems.
• Ensure compliance with global regulatory requirements (FDA, EMA, ICH, GDPR, 21 CFR Part 11).
• Support Gilead inspections with a focus on GxP digital Compliance (CSV, Data Integrity etc.).
• Oversee validation lifecycle for systems such as Veeva Vault and LIMS.
• Define and execute the digital quality roadmap in partnership with IT, Clinical, Regulatory, and Product Development.
• Guide and integrate agile software development in a regulated environment.
• Lead risk assessments and CAPA processes for digital systems.
• Drive innovation through advanced technologies such as AI, machine learning, and data analytics.
• Provide expert guidance and training on digital quality principles.
• Mentor and develop talent, fostering a culture of inclusion, accountability, and continuous improvement.

Requirements

• Bachelor’s degree in a scientific, computer science, or engineering field
• 16+ years of relevant experience with a BS/BA, or 14+ years with an MS/MA, MBA, or PhD
• Proven leadership in digital quality, software validation, and regulatory compliance
• Strong cross-functional collaboration and strategic influence
• Excellent analytical, communication, and problem-solving skills
• Master’s degree or quality certifications (e.g., ASQ Certified Quality Engineer) preferred
• Experience with Veeva Quality Suite or similar eQMS platforms, and SAP preferred
• Familiarity with AI, machine learning, and data analytics in a GxP environment preferred
• Knowledge of agile software development methodologies preferred
• Mastery of GMP, quality systems, Computer Validation and Data Integrity preferred
• Visionary ability to implement disruptive technologies at scale preferred
• Data-driven approach to risk, trends, and process optimization preferred

Tech Stack

• Vault

Benefits

• company-sponsored medical, dental, vision, and life insurance plans
• discretionary annual bonus
• discretionary stock-based long-term incentives
• paid time off