Sr. Director R&D E-Systems & AI Quality

Gilead Sciences•Foster City, CA

17d

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 POSITION OVERVIEW: Would you like to play a crucial role in developing life-saving therapies? Are you excited to use your scientific insight to partner with internal teams, and external partners as we strive to cure unmet medical needs? 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 as well as 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.

Requirements

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

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
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.
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

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.

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