Sr. Director R&-Systems & AI Quality

Position: Sr. Director R&D E-Systems & AI Quality
Job Description

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.

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; and (2) building partnerships across Development, IT and other functions and elevating Quality as a trusted advisor.

The ideal candidate will have a strong point of view and be able to effectively influence stakeholders cross‑functionally with proven experience in modernizing Quality & Compliance practices, standards and approaches to novel technologies.

KEY 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…