Director, Digital Quality

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About the role

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   EXAMPLE RESPONSIBILITIES: • Set the global Digital Quality strategy and roadmap • Define the target state, strategic themes, capability model, and multi-year roadmap for Digital Quality. • Maintain a portfolio of initiatives aligned with Quality objectives, regulatory priorities, enterprise architecture, and available investment. • Establish measurable outcomes, including compliance effectiveness, cycle-time reduction, right-first-time performance, user adoption, data quality, and realized benefits. • Lead end-to-end Quality process mapping and optimization • Map current- and future-state processes across sites, regions, and GxP domains, including roles, decisions, controls, systems, data, handoffs, pain points, and performance measures. • Identify opportunities to simplify, standardize, digitize, automate, or retire processes before selecting technology. • Maintain process, capability, system, and data maps to support investment decisions, integration planning, and global standardization. • Partner with process owners to define requirements, target operating models, controls, and adoption plans. • Assess and recommend new digital tools • Establish a consistent intake and assessment method for digital tools, platforms, automation, analytics, and AI use cases. • Evaluate intended use, user need, business value, GxP impact, patient and product risk, data integrity, privacy, cybersecurity, interoperability, accessibility, scalability, supplier maturity, total cost, and support model. • Lead market scans, demonstrations, proofs of concept, pilots, supplier due diligence, and fit-gap assessments. • Recommend whether to adopt, configure, integrate, scale, defer, or reject proposed solutions based on documented evidence. • Prevent technology-led implementations by confirming that each tool addresses a defined process need and has measurable success criteria. • Establish Digital Quality governance and assurance • Define decision rights, design principles, architecture guardrails, stage gates, risk criteria, and governance forums for the Digital Quality portfolio. • Apply risk-based lifecycle assurance based on intended use and process risk, including requirements, supplier evidence, testing, traceability, release, change control, periodic review, and retirement. • Set governance for AI-enabled Quality solutions, including approved use cases, human oversight, data provenance, model performance, explainability, monitoring, drift, retraining, and accountability for decisions. • Ensure electronic records, signatures, audit trails, integrations, master data, and reporting controls me

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