Exec Director, Head of Digital 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

Gilead Sciences is seeking a Head of Digital Quality dynamic experienced and visionary leader to serve as the Executive Director of Digital Quality. The incumbent will lead a team of over 30 highly technical digital and AI experts that will drive the digital future of Global Quality. This pivotal role is also responsible for shaping and executing the digital quality vision beyond Global Quality and will be an essential partner in the Gilead digital strategy with strategic influence spanning Quality IT Regulatory Clinical and Product Development functions. The ideal candidate will bring deep expertise in GxP digital systems regulatory compliance and agile innovation along with a proven ability to lead cross-functional interacting teams and build high-performing inclusive cultures. This is a high-impact leadership opportunity to drive digital transformation across quality systems and ensure the highest standards of safety compliance and performance across Gileads global product development and manufacturing landscape. The incumbent will also lead the PDM Data and Digital Strategy Committee.

Key Responsibilities

Strategic Leadership & Influence

Lead the digital quality function with full accountability for strategy execution and performance.

Build and direct a diverse digital quality team; drive cross-functional collaboration with IT manufacturing regulatory and supply chain

Champion digital transformation (automation AI/ML advanced analytics) across all GMP quality activities ensuring harmonization and standardization including SaMD eQMS and data platforms.

Partner with senior executive leadership on strategic issues with Gilead-wide impact.

Build collaborative relationships across functions and with external partners to drive innovation and compliance.

Define and communicate a compelling quality vision to inspire change and unify stakeholders Quality Management & Compliance

Oversee Develop and maintain the Quality Management System (QMS) for digital health products and GxP computerized systems.

Ensure compliance with global regulatory requirements (FDA EMA ICH GDPR 21 CFR Part 11).

Support Gilead inspections with a focus on GxP digital Compliance (CSV Data Integrity etc.)

Oversee validation lifecycle for systems such as Veeva Vault and LIMS.

Digital Innovation & Risk Management

Define and execute the digital quality roadmap in partnership with IT Clinical Regulatory and Product Development.

Guide and integrate agile software development in a regulated environment.

Lead risk assessments and CAPA processes for digital systems.

Drive innovation through advanced technologies such as AI machine learning and data analytics.

Collaborate with IT and data science teams to leverage enterprise data structured data models and knowledge graphs for advanced analytics regulatory reporting and decision making

People Leadership:

Provide expert guidance and training on digital quality principles.

Mentor and develop talent fostering a culture of inclusion accountability and continuous improvement.

Demonstrate Gileads People Leadership Accountabilities:

Developing Talent

Enabling High Performance

Leading Inclusively

Driving Results

Qualifications:

Required:

Bachelors degree in a scientific computer science or engineering field.

16 years of relevant experience with a BS/BA or 14 years with an MS/MA MBA or PhD.

Proven leadership in digital quality software validation and regulatory compliance.

Strong cross-functional collaboration and strategic influence.

Excellent analytical communication and problem-solving skills.

Preferred:

Masters degree or quality certifications (e.g. ASQ Certified Quality Engineer).

Experience with Veeva Quality Suite or similar eQMS platforms and SAP

Familiarity with AI machine learning and data analytics in a GxP environment.

Knowledge of agile software development methodologies

Quality & Compliance Expertise: Mastery of GMP quality systems Computer Validation and Data Integrity

Digital Transformation Leadership: Visionary ability to implement disruptive technologies at scale

Analytical & Strategic Thinking: Data-driven approach to risk trends and process optimization

The salary range for this position is:

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 theKnow Your Rights poster.

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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.