Exec Director, Head of Digital Quality

Gilead Sciences • Foster City, CA

6d • $255,425 - $363,660

About The Position

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Gilead Sciences is seeking a Head of Digital Quality dynamic, experienced, and visionary leader to serve as the Executive Director of Digital Quality. The incumbent will lead a team of over 30 highly technical digital and AI experts that will drive the digital future of Global Quality. This pivotal role is also responsible for shaping and executing the digital quality vision beyond Global Quality and will be an essential partner in the Gilead digital strategy, with strategic influence spanning Quality, IT, Regulatory, Clinical, and Product Development functions. The ideal candidate will bring deep expertise in GxP digital systems, regulatory compliance, and agile innovation, along with a proven ability to lead cross-functional interacting teams and build high-performing, inclusive cultures. This is a high-impact leadership opportunity to drive digital transformation across quality systems and ensure the highest standards of safety, compliance, and performance across Gilead’s global product development and manufacturing landscape. The incumbent will also lead the PDM Data and Digital Strategy Committee.

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.
• Quality & Compliance Expertise: Mastery of GMP, quality systems, Computer Validation and Data Integrity
• Digital Transformation Leadership: Visionary ability to implement disruptive technologies at scale
• Analytical & Strategic Thinking: Data-driven approach to risk, trends, and process optimization

Nice To Haves

• Master’s degree or quality certifications (e.g., ASQ Certified Quality Engineer).
• Experience with Veeva Quality Suite or similar eQMS platforms, and SAP
• Familiarity with AI, machine learning, and data analytics in a GxP environment.
• Knowledge of agile software development methodologies

Responsibilities

• 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. Define and communicate a compelling quality vision to inspire change and unify stakeholders, Quality Management & 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. Collaborate with IT and data science teams to leverage enterprise data, structured data models, and knowledge graphs for advanced analytics, regulatory reporting, and decision making People Leadership:
• Provide expert guidance and training on digital quality principles.
• Mentor and develop talent, fostering a culture of inclusion, accountability, and continuous improvement.
• Demonstrate Gilead’s People Leadership Accountabilities:
• Developing Talent
• Enabling High Performance
• Leading Inclusively
• Driving Results

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Number of Employees: 5,001-10,000 employees