Director, Digital Quality

Job description

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 roadmapDefine 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 optimizationMap 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 toolsEstablish 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 assuranceDefine 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 meet applicable regulatory and company expectations. Drive implementation, adoption, and value realizationProvide Quality leadership through product selection, design, configuration, testing, deployment, stabilization, and continuous improvement. Lead stakeholder engagement, communications, training, readiness assessments, and adoption measurement across global functions and sites. Monitor solution performance, incidents, compliance signals, user feedback, benefits, and emerging risks throughout the lifecycle. Manage portfolio risks, dependencies, budgets, resource needs, suppliers, and executive reporting. Develop organizational capabilityBuild digital literacy, process-mapping capability, product-management practices, and risk-based assurance skills across Quality. Lead and develop internal staff and cross-functional teams; engage external specialists when needed. Represent Quality in enterprise digital, data, AI, architecture, cybersecurity, and investment forums. Monitor evolving regulations, industry practices, and emerging technologies and translate them into practical Quality standards and roadmaps. REQUIREMENTS: We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role. Required Qualifications Bachelor’s degree with at least 10 years of relevant experience in Digital Quality, Quality systems, digital transformation, computer system assurance or validation, process excellence, product management, or a related discipline. Experience in the biopharmaceutical, medical device, or another highly regulated life-sciences environment. Demonstrated experience defining strategy and delivering global digital programs across multiple functions, sites, or regions. Hands-on experience with process mapping, value-stream analysis, requirements definition, fit-gap assessment, and future-state design. Experience assessing and implementing digital platforms, SaaS solutions, workflow automation, analytics, data products, or AI-enabled tools. Knowledge of risk-based computer software assurance, computerized system validation, electronic records and signatures, data integrity, supplier assurance, and system lifecycle management. Experience establishing governance, prioritizing portfolios, preparing business cases, managing budgets, and measuring benefits. Strong analytical, facilitation, change-management, project, product, and vendor-management skills. Demonstrated ability to influence senior leaders and lead multidisciplinary teams without direct authority. Strong written and verbal communication skills, including the ability to prepare concise recommendations and decision materials. Ability to travel as needed. Preferred Qualifications Advanced degree in Quality, life sciences, engineering, information systems, business, data science, or a related discipline. Experience leading an enterprise Digital Quality strategy, capability model, or multi-year transformation roadmap. Experience with electronic quality management, document and learning management, laboratory, manufacturing, clinical, regulatory, analytics, integration, or collaboration platforms. Experience conducting market scans, supplier due diligence, proofs of concept, pilots, and formal digital-tool evaluations. Experience applying product-management, enterprise-architecture, data-governance, or organizational change-management practices. Experience establishing governance for artificial intelligence or machine-learning solutions in a regulated environment. Knowledge of cloud services, cybersecurity, privacy, integration patterns, master data, metadata, and third-party risk. Experience rationalizing application portfolios and supporting global process and technology standardization. Required Knowledge and Skills Expert understanding of global GxP Quality processes and the drug-development and product lifecycle, with the ability to connect process, data, technology, and control requirements. Strong knowledge of digital Quality platforms and how they support regulated business processes. Working knowledge of AI and machine-learning risks and controls, including intended-use definition, human oversight, data provenance, performanc