Sr. Director R&-Systems & AI Quality

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