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

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

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 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 :

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

The salary range for this position is : $243100.00 - $314600.00. 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.

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 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 the Know 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.

For Current Gilead Employees and Contractors :

Please apply via the Internal Career Opportunities portal in Workday.

Required Experience :

Exec

Key Skills

Laboratory Experience,Vendor Management,Design Controls,C / C++,FDA Regulations,Intellectual Property Law,ISO 13485,Research Experience,SolidWorks,Research & Development,Internet Of Things,Product Development

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 243100 - 314600