Director, AI Systems Quality & Governance, R&D

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

AtGileadour pursuit of a healthier world for all people has yielded a cure for hepatitis C revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the worlds most devastating diseases united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to aDirector AI Systems Quality & Governance R&D and Gilead you will establish and operationalize the quality framework for artificial intelligence across Research & Development.

Reporting to the Senior Director of eSystems Quality for R&D this role will define how AI-enabled solutions are assessed developed tested implemented monitored changed and retired within a regulated environment. The Director will ensure that quality data integrity risk management and appropriate controls are built into AI solutions by design. This individual will also establish the documentation testing traceability and ongoing monitoring needed to demonstrate that AI solutions remain fit for intended use and inspection ready throughout their lifecycle.

Extensive experience within a Quality organization is not required. We are seeking someone with strong experience in AI data digital products technology risk or controls who is willing to develop a deeper understanding of GxP regulations and apply guidance from colleagues with expertise in Quality validation data integrity and regulated R&D processes.

This is an onsite position that operates within our policy (hybrid on site Tuesday-Thursday).

Overview of Responsibilities:

Establish the AI Development Lifecycle

• Design implement and maintain a risk-based AI Development Lifecycle for R&D.
• Define requirements for intake intended use risk classification data readiness development testing release monitoring change management periodic review and retirement.
• Establish required documentation evidence reviews approvals and decision points across the lifecycle.
• Ensure that quality and control requirements are incorporated during solution design and development rather than added at the end.
• Align AI lifecycle requirements with applicable GxP regulations Gilead procedures data-integrity principles and inspection expectations.

Define AI Risk and Control Requirements

• Develop a risk and control framework for AI-enabled solutions.
• Evaluate risks associated with model performance unreliable outputs bias data quality drift explainability automation human oversight privacy security and vendor-controlled changes.
• Define controls that can be implemented tested monitored and supported by objective evidence.
• Establish requirements for human review intervention override escalation and documentation.
• Determine how control effectiveness will be demonstrated throughout the lifecycle.
• Work with GxP Quality subject-matter experts to determine when formal change control deviation investigation CAPA or other Quality-system processes apply.

Establish Data Quality Requirements

• Define requirements for data used to train configure test validate and operate AI solutions.
• Develop a framework for grading data based on accuracy completeness consistency representativeness lineage provenance timeliness criticality and fitness for intended use.
• Ensure that data sources transformations exclusions assumptions and limitations are documented.
• Define traceability expectations across source data model versions requirements testing outputs and production use.
• Evaluate how patient clinical proprietary and company data may be used by internal models external platforms and vendors.

Define AI Testing and Assurance Strategies

• Establish risk-based testing and assurance approaches for AI-enabled solutions.
• Define expectations for requirements acceptance criteria test data test methods traceability and objective evidence.
• Ensure that test strategies address accuracy reliability reproducibility boundary conditions failure scenarios bias human oversight and real-world performance.
• Define how teams will demonstrate that AI-generated outputs are correct appropriate and reliable for their intended use.
• Determine when statistical testing expert review comparative testing deterministic testing or production monitoring is appropriate.
• Ensure that model limitations prohibited uses expected failure modes and required user actions are documented.

Establish Monitoring and Periodic Review

• Define requirements for monitoring AI solutions after implementation.
• Establish expectations for monitoring model performance model drift data drift output quality exceptions human overrides unintended outcomes and vendor changes.
• Define meaningful metrics thresholds alert criteria and escalation pathways.
• Establish triggers for investigation retraining additional testing revalidation suspension or retirement.
• Define risk-based periodic review requirements focused on continued fitness for intended use.
• Ensure that monitoring responsibilities and decision rights are clearly assigned.

Evaluate AI Models Platforms and Vendors

• Assess the risks and controls associated with open closed hosted embedded and vendor-managed AI models.
• Evaluate vendor documentation related to model design training data performance security privacy monitoring and change management.
• Determine whether vendor evidence is sufficient to support Gileads intended use.
• Identify additional testing controls contractual provisions or monitoring needed to address gaps.
• Define expectations for vendor notification of model updates retraining material changes incidents and performance issues.
• Evaluate whether company data or user inputs may be retained or used to train external models.

Ensure Inspection Readiness

• Establish documentation and traceability expectations for AI-enabled solutions.
• Ensure that intended use risks requirements testing approvals limitations monitoring changes and decisions are supported by retrievable evidence.
• Confirm that assurance activities are proportionate to risk and defensible during internal audits and health authority inspections.
• Help technical and business teams explain how AI solutions work how risks are controlled and how continued performance is demonstrated.
• Identify and address documentation testing or control gaps before inspection.
• Apply lessons learned from audits inspections incidents and implementation experience to improve the AI Development Lifecycle.

Build AI Quality Capabilities

• Increase understanding of AI technologies risks and controls across R&D and eSystems Quality.
• Develop playbooks templates decision tools examples and role-based training.
• Explain AI risks and assurance expectations in language appropriate for technical business Quality and executive audiences.
• Help Quality colleagues understand how established GxP risk and control principles apply to AI-enabled solutions.
• Continue to develop personal knowledge of GxP regulations validation data integrity and regulated R&D processes through collaboration with experienced team members.

Provide Direction for the R&D Quality Intelligence Platform

• Provide product direction for a platform that connects and analyzes information across R&D Quality processes.
• Define requirements for structured data common taxonomies data quality traceability and analytics.
• Advance the platform from reporting toward Quality intelligence and decision support.
• Enable identification of emerging risks recurring issues control effectiveness CAPA effectiveness and areas requiring earlier intervention.
• Ensure that AI-enabled platform capabilities follow the same lifecycle testing monitoring and governance requirements established for other R&D AI solutions.

Requirements:

We are all different yet we all use our unique contributions to serve patients. Please see the following qualifications and skills we seek for this role.

U.S. Education & Experience

• BA/BS in computer science data science engineering information systems life sciences or related discipline and 12 years of relevant experience OR
• MA/MS in computer science data science engineering information systems life sciences or related discipline and 10 years of relevant experience OR
• PhD in computer science data science engineering information systems life sciences or related discipline and 8 years of relevant experience

• Significant experience in AI machine learning advanced analytics digital products data governance technology risk controls or related fields.

• Experience implementing evaluating or governing AI-enabled solutions in a complex enterprise environment.

• Understanding of how AI models are developed tested deployed monitored changed and retired.

• Experience evaluating model performance data quality drift human oversight vendors and operational controls.

• Ability to translate technical risks into clear implementable and testable requirements.

• Strong documentation communication facilitation and stakeholder-management skills.

• Willingness to develop deeper expertise in GxP regulations Quality systems validation data integrity and inspection readiness.

Preferred Qualifications

• Experience within pharmaceutical biotechnology healthcare medical device financial services or another regulated industry.

• Familiarity with Clinical Operations Regulatory Affairs Patient Safety Clinical Data Management Medical Affairs or related R&D processes.

• Experience developing AI governance frameworks lifecycle standards model-risk frameworks or control requirements.

• Experience evaluating AI vendors platforms and embedded AI capabilities.

• Familiarity with responsible AI data lineage model documentation internal controls validation or risk-based assurance.

• Product-management or product-owner experience.

• Advanced degree in technical scientific data or business discipline.

HOW YOU WILL KNOW YOU ARE A GOOD FIT

You may be a good fit for this role if:

• You understand risk and controls and can determine whether they work in practice.

• You ask questions that expose assumptions limitations and potential failure points.

• You document requirements decisions risks and evidence clearly.

• You can evaluate a technical solution without needing to be the person who built it.

• You can assess vendor claims and identify where additional evidence is needed.

• You balance attention to detail with an end-to-end systems-level perspective.

• You are willing to learn from colleagues with deeper GxP and traditional Quality expertise.

• You believe quality should be built into AI solutions by design.

• You can help ensure that AI-enabled solutions are reliable controlled and inspection ready.

People Leader Accountabilities:

• Create Inclusion -knowingthe business value of diverse teams modeling inclusion and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills experience aspirations and potential of their employees and coach them on current performance and future potential. They ensure employeesare receivingthe feedback and insight needed to growdevelopand realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals purpose and organizationalobjectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is: $210375.00 - $272250.00. 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:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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 disabilitygenetic 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 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 for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

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.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

Please apply via the Internal Career Opportunities portal in Workday.