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

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.

EXAMPLE COMPETENCIES AND RESPONSIBILITIES:

Strategy 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

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.

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*.

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.

For jobs in the United States:

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. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the  legal duty to furnish information; or (d) otherwise protected by law.
 

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For Current Gilead Employees and Contractors:

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