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Exec Director, Head of Digital Quality

Exec Director, Head of Digital Quality

Gilead SciencesSan Francisco, CA, United States
1 day ago
Job type
  • Full-time
Job description

Gilead Sciences is seeking a Head of Digital Quality, a 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.

Key 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.

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.

    • Digital Innovation & Risk Management

  • 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.

    • 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.

    • Qualifications

  • 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.

    • Preferred

  • 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.
  • 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.

    • Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences.

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    Director Of Quality • San Francisco, CA, United States