Gilead Sciences
Sr. Director R&D E-Systems & AI Quality
Gilead Sciences, San Francisco, California, United States, 94199
Sr. Director R&D E-Systems & AI Quality at Gilead Sciences
Overview
Would you like to play a crucial role in developing life-saving therapies? The Central Quality team within R&D Quality (RDQ) is seeking a seasoned leader to activate Electronic Systems and Artificial Intelligence Quality for the Development organization. In this role you will focus on two critical areas for the business: 1) defining and executing the R&D Quality Digital & Controls Strategy inclusive of understanding the implications of digital tools such as Artificial Intelligence (AI), Machine Learning (ML), Robotic Process Automation (RPA) and other digital tools, and 2) building partnerships across Development, IT and other functions and elevate Quality as a trusted advisor. The ideal candidate will have a strong point of view and be able to effectively influence stakeholders cross-functionally and proven experience in modernizing Quality & Compliance practices, standards and approaches to novel technologies.
Position overview excerpt adapted from the original language to reflect responsibilities and expectations for this role.
Responsibilities
Define and execute the Quality strategy for Development Electronic Systems including the use of Artificial Intelligence (AI), establishing clear standards, goals, and a long-term roadmap that ensures compliance, data integrity, and business enablement Enable the adoption of emerging technologies (e.g. RPA, AI, ML, LLMs) by embedding fit-for-purpose quality controls into processes, ensuring Quality serves as a driver of innovation rather than a barrier and that digital solutions enable compliance, efficiency, and innovation Champion the use of automation and digital solutions to enable CSV / CSA activities and increase transparency Drive a risk-based approach to validation and eSystem related data integrity Partner with IT and Business functions to modernize E-Systems Quality and maintain alignment with the evolving regulatory landscape Champion unification of Electronic Systems policies and procedures across PDM, Commercial, and IT Lead and facilitate change management strategy and activities related to strategy and process change Operational Excellence and Oversight
Oversee Development systems and applications, as well as the use and applicability of emerging technologies such as AI and ML for Development Engage and advise in cross-functional governance to ensure Quality is a key consideration in technology initiatives, serving as a trusted advisor to IT and business stakeholders Advise and support the R&D Data Governance Council with a focus on Data Integrity, Privacy and Protection Serve as Development Global Process Owner for E-systems Quality incl. process, issues, risks, inspection and audit requests Identify and implement process improvements to enhance output and efficiency of E-System compliance Define and implement meaningful metrics to measure E-Systems Quality performance, increasing transparency, driving accountability Oversee the execution of Development QA activities, including testing, validation, and risk management ensuring alignment with modern CSA principles Ensures compliance with data privacy and security regulations and maintain a high level of data integrity Anticipate and mitigate risks across the Development E-Systems portfolio, proactively resolving delivery roadblocks and aligning stakeholders Utilize data-driven insights to perform trend analysis on CAPAs, deviations, and other quality events, identifying systemic issues as well as actionable strategies that enhance compliance, operational efficiency, and proactive risk management Ensure Development E-Systems maintain continuous audit readiness, while leading efficient audit execution support through coordinated responses and effective stakeholder engagement. Review, assess and defend critical audit observations related to E-Systems in Development Manage vendor relationships and ensure cost-effective, value-aligned execution across strategic initiatives Drive accountability for maintaining SaaS vendor-managed eSystems in a validated and compliant state, ensuring alignment with data integrity (DI) standards This includes shaping enterprise-level strategies that mitigate risk, strengthen regulatory readiness, and enhance data governance and system resilience across the digital ecosystem. Competencies
Clearly understands the value and challenges with adoption of digital tools including AI, ML, RPA Innovation Enablement – Forward-looking mindset with the ability to embrace and integrate emerging technologies (e.g. AI/ML, cloud, and automation) into regulated environments Lead, influence and unify various stakeholders with different backgrounds, strengths, and abilities to create high-functioning teams Cross-Functional Collaboration – Skilled at building partnerships across IT, R&D, Manufacturing, and Commercial functions; trusted advisor and influencer Change Leadership – Proven ability to lead cultural and organizational change Risk-Based Thinking – Expertise in applying risk management principles to simplify processes (e.g., CSA over CSV) while maintaining compliance Continuous Improvement – Lean mindset with experience streamlining processes, harmonizing SOPs, and reducing silos Excellent communication skills, active listener Demonstrated complex problem-solving skills and creative solution development and ongoing issue resolution Ability to make effective, defensible business decisions in the best interest of Gilead and the project / program Recruit, manage and provide leadership and guidance to Quality Learning and Development staff/team members Lead, mentor and coach project team and junior team members U.S. Education & Experience
Deep understanding of R&D / Development system / application quality assurance methodologies, testing techniques, and risk management Strong familiarity with relevant R&D electronic systems regulations and standards, including GxP regulations in the biopharmaceutical industry Proven ability to lead and motivate a team, provide guidance, and drive change Ability to identify and resolve complex quality and compliance issues Good understanding of and experience with change management principles Bachelor of Science or Arts degree, advance degree preferred 13+ years of pharmaceutical industry – IT and / or Development Demonstrated excellence in written and oral communication Experience managing and overseeing external vendors Ability to develop and manage a budget Significant experience working with and establishing strong relationships across R&D functions Applied knowledge of performance measurements (e.g., metrics, dashboards) Proven ability to delegate in matrix environment, predict issues, anticipate risks and solve problems Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives Strong EQ soft and interpersonal skills and with proven understanding of team dynamics Strong negotiation and conflict resolution skills Ability to recognize and make hard decisions that directly impact staff When needed, ability to travel The salary range for this position is: $243,100.00 - $314,600.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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. Please note: For Additional Benefits Information, visit the Gilead Careers page for compensation, benefits and wellbeing. Current Opportunities and Notices
For Current Gilead Employees And Contractors: Please apply via the Internal Career Opportunities portal in Workday.
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Define and execute the Quality strategy for Development Electronic Systems including the use of Artificial Intelligence (AI), establishing clear standards, goals, and a long-term roadmap that ensures compliance, data integrity, and business enablement Enable the adoption of emerging technologies (e.g. RPA, AI, ML, LLMs) by embedding fit-for-purpose quality controls into processes, ensuring Quality serves as a driver of innovation rather than a barrier and that digital solutions enable compliance, efficiency, and innovation Champion the use of automation and digital solutions to enable CSV / CSA activities and increase transparency Drive a risk-based approach to validation and eSystem related data integrity Partner with IT and Business functions to modernize E-Systems Quality and maintain alignment with the evolving regulatory landscape Champion unification of Electronic Systems policies and procedures across PDM, Commercial, and IT Lead and facilitate change management strategy and activities related to strategy and process change Operational Excellence and Oversight
Oversee Development systems and applications, as well as the use and applicability of emerging technologies such as AI and ML for Development Engage and advise in cross-functional governance to ensure Quality is a key consideration in technology initiatives, serving as a trusted advisor to IT and business stakeholders Advise and support the R&D Data Governance Council with a focus on Data Integrity, Privacy and Protection Serve as Development Global Process Owner for E-systems Quality incl. process, issues, risks, inspection and audit requests Identify and implement process improvements to enhance output and efficiency of E-System compliance Define and implement meaningful metrics to measure E-Systems Quality performance, increasing transparency, driving accountability Oversee the execution of Development QA activities, including testing, validation, and risk management ensuring alignment with modern CSA principles Ensures compliance with data privacy and security regulations and maintain a high level of data integrity Anticipate and mitigate risks across the Development E-Systems portfolio, proactively resolving delivery roadblocks and aligning stakeholders Utilize data-driven insights to perform trend analysis on CAPAs, deviations, and other quality events, identifying systemic issues as well as actionable strategies that enhance compliance, operational efficiency, and proactive risk management Ensure Development E-Systems maintain continuous audit readiness, while leading efficient audit execution support through coordinated responses and effective stakeholder engagement. Review, assess and defend critical audit observations related to E-Systems in Development Manage vendor relationships and ensure cost-effective, value-aligned execution across strategic initiatives Drive accountability for maintaining SaaS vendor-managed eSystems in a validated and compliant state, ensuring alignment with data integrity (DI) standards This includes shaping enterprise-level strategies that mitigate risk, strengthen regulatory readiness, and enhance data governance and system resilience across the digital ecosystem. Competencies
Clearly understands the value and challenges with adoption of digital tools including AI, ML, RPA Innovation Enablement – Forward-looking mindset with the ability to embrace and integrate emerging technologies (e.g. AI/ML, cloud, and automation) into regulated environments Lead, influence and unify various stakeholders with different backgrounds, strengths, and abilities to create high-functioning teams Cross-Functional Collaboration – Skilled at building partnerships across IT, R&D, Manufacturing, and Commercial functions; trusted advisor and influencer Change Leadership – Proven ability to lead cultural and organizational change Risk-Based Thinking – Expertise in applying risk management principles to simplify processes (e.g., CSA over CSV) while maintaining compliance Continuous Improvement – Lean mindset with experience streamlining processes, harmonizing SOPs, and reducing silos Excellent communication skills, active listener Demonstrated complex problem-solving skills and creative solution development and ongoing issue resolution Ability to make effective, defensible business decisions in the best interest of Gilead and the project / program Recruit, manage and provide leadership and guidance to Quality Learning and Development staff/team members Lead, mentor and coach project team and junior team members U.S. Education & Experience
Deep understanding of R&D / Development system / application quality assurance methodologies, testing techniques, and risk management Strong familiarity with relevant R&D electronic systems regulations and standards, including GxP regulations in the biopharmaceutical industry Proven ability to lead and motivate a team, provide guidance, and drive change Ability to identify and resolve complex quality and compliance issues Good understanding of and experience with change management principles Bachelor of Science or Arts degree, advance degree preferred 13+ years of pharmaceutical industry – IT and / or Development Demonstrated excellence in written and oral communication Experience managing and overseeing external vendors Ability to develop and manage a budget Significant experience working with and establishing strong relationships across R&D functions Applied knowledge of performance measurements (e.g., metrics, dashboards) Proven ability to delegate in matrix environment, predict issues, anticipate risks and solve problems Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives Strong EQ soft and interpersonal skills and with proven understanding of team dynamics Strong negotiation and conflict resolution skills Ability to recognize and make hard decisions that directly impact staff When needed, ability to travel The salary range for this position is: $243,100.00 - $314,600.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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. Please note: For Additional Benefits Information, visit the Gilead Careers page for compensation, benefits and wellbeing. Current Opportunities and Notices
For Current Gilead Employees And Contractors: Please apply via the Internal Career Opportunities portal in Workday.
#J-18808-Ljbffr