Director, 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

EXAMPLE RESPONSIBILITIES:

• Set the global Digital Quality strategy and roadmap
  • Define the target state strategic themes capability model and multi-year roadmap for Digital Quality.
  • Maintain a portfolio of initiatives aligned with Quality objectives regulatory priorities enterprise architecture and available investment.
  • Establish measurable outcomes including compliance effectiveness cycle-time reduction right-first-time performance user adoption data quality and realized benefits.
• Lead end-to-end Quality process mapping and optimization
  • Map current- and future-state processes across sites regions and GxP domains including roles decisions controls systems data handoffs pain points and performance measures.
  • Identify opportunities to simplify standardize digitize automate or retire processes before selecting technology.
  • Maintain process capability system and data maps to support investment decisions integration planning and global standardization.
  • Partner with process owners to define requirements target operating models controls and adoption plans.
• Assess and recommend new digital tools
  • Establish a consistent intake and assessment method for digital tools platforms automation analytics and AI use cases.
  • Evaluate intended use user need business value GxP impact patient and product risk data integrity privacy cybersecurity interoperability accessibility scalability supplier maturity total cost and support model.
  • Lead market scans demonstrations proofs of concept pilots supplier due diligence and fit-gap assessments.
  • Recommend whether to adopt configure integrate scale defer or reject proposed solutions based on documented evidence.
  • Prevent technology-led implementations by confirming that each tool addresses a defined process need and has measurable success criteria.
• Establish Digital Quality governance and assurance
  • Define decision rights design principles architecture guardrails stage gates risk criteria and governance forums for the Digital Quality portfolio.
  • Apply risk-based lifecycle assurance based on intended use and process risk including requirements supplier evidence testing traceability release change control periodic review and retirement.
  • Set governance for AI-enabled Quality solutions including approved use cases human oversight data provenance model performance explainability monitoring drift retraining and accountability for decisions.
  • Ensure electronic records signatures audit trails integrations master data and reporting controls meet applicable regulatory and company expectations.
• Drive implementation adoption and value realization
  • Provide Quality leadership through product selection design configuration testing deployment stabilization and continuous improvement.
  • Lead stakeholder engagement communications training readiness assessments and adoption measurement across global functions and sites.
  • Monitor solution performance incidents compliance signals user feedback benefits and emerging risks throughout the lifecycle.
  • Manage portfolio risks dependencies budgets resource needs suppliers and executive reporting.
• Develop organizational capability
  • Build digital literacy process-mapping capability product-management practices and risk-based assurance skills across Quality.
  • Lead and develop internal staff and cross-functional teams; engage external specialists when needed.
  • Represent Quality in enterprise digital data AI architecture cybersecurity and investment forums.
  • Monitor evolving regulations industry practices and emerging technologies and translate them into practical Quality standards and roadmaps.

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.

Required Qualifications

• Bachelors degree with at least 10 years of relevant experience in Digital Quality Quality systems digital transformation computer system assurance or validation process excellence product management or a related discipline.
• Experience in the biopharmaceutical medical device or another highly regulated life-sciences environment.
• Demonstrated experience defining strategy and delivering global digital programs across multiple functions sites or regions.
• Hands-on experience with process mapping value-stream analysis requirements definition fit-gap assessment and future-state design.
• Experience assessing and implementing digital platforms SaaS solutions workflow automation analytics data products or AI-enabled tools.
• Knowledge of risk-based computer software assurance computerized system validation electronic records and signatures data integrity supplier assurance and system lifecycle management.
• Experience establishing governance prioritizing portfolios preparing business cases managing budgets and measuring benefits.
• Strong analytical facilitation change-management project product and vendor-management skills.
• Demonstrated ability to influence senior leaders and lead multidisciplinary teams without direct authority.
• Strong written and verbal communication skills including the ability to prepare concise recommendations and decision materials.
• Ability to travel as needed.

Preferred Qualifications

• Advanced degree in Quality life sciences engineering information systems business data science or a related discipline.
• Experience leading an enterprise Digital Quality strategy capability model or multi-year transformation roadmap.
• Experience with electronic quality management document and learning management laboratory manufacturing clinical regulatory analytics integration or collaboration platforms.
• Experience conducting market scans supplier due diligence proofs of concept pilots and formal digital-tool evaluations.
• Experience applying product-management enterprise-architecture data-governance or organizational change-management practices.
• Experience establishing governance for artificial intelligence or machine-learning solutions in a regulated environment.
• Knowledge of cloud services cybersecurity privacy integration patterns master data metadata and third-party risk.
• Experience rationalizing application portfolios and supporting global process and technology standardization.

Required Knowledge and Skills

• Expert understanding of global GxP Quality processes and the drug-development and product lifecycle with the ability to connect process data technology and control requirements.
• Strong knowledge of digital Quality platforms and how they support regulated business processes.
• Working knowledge of AI and machine-learning risks and controls including intended-use definition human oversight data provenance performance criteria monitoring drift change and retraining governance.
• Ability to distinguish business criticality GxP impact and process risk and translate the assessment into proportionate assurance activities.
• Ability to convert ambiguous business needs into clear problem statements process maps user requirements evaluation criteria roadmaps and investment recommendations.
• Strong facilitation critical-thinking negotiation and conflict-resolution skills.
• Ability to communicate direction trade-offs risks status and value to executives steering committees process owners technical teams and end users.

Commitment to global standardization while accommodating justified regional or functional requirements.

The salary range for this position is: $191250.00 - $247500.00. 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.

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.

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.

Please apply via the Internal Career Opportunities portal in Workday.