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

Benefits

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

digital qualitysoftware validationregulatory compliancedata analyticsAImachine learningagile software developmentrisk assessmentsCAPA processesquality management system

Soft Skills

leadershipcross-functional collaborationstrategic influenceanalytical skillscommunication skillsproblem-solving skillsmentoringinclusionaccountabilitycontinuous improvement

Certifications

Bachelor’s degreeMaster’s degreeASQ Certified Quality Engineer