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:

• 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

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:

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