At Gilead, weāre creating a healthier world for all people. For more than 35 years, weāve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer ā 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 worldās biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
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Every member of Gileadās 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 weāre looking for the next wave of passionate and ambitious people ready to make a direct impact.
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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
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The Executive Director, Risk and Proactive Quality is a senior enterprise Quality leader responsible for defining, governing, and advancing the global strategy for Quality Risk Management and Proactive Quality across the organization. This role serves as the Global Business Process Owner (BPO) for Risk and has direct leadership accountability for the Change Control, Medical Device & Combination Product Risk, and Proactive Human and Organizational Performance (HOP) global process owners.
This leader provides strategic direction and oversight to ensure that riskābased thinking, proactive quality practices, and humanācentric performance principles are deeply embedded across the Pharmaceutical Quality System (PQS) and operations. The role is accountable for designing, implementing, and sustaining compliant, scalable, and efficient global processes that enable early risk identification, effective risk mitigation, and continuous improvement aligned with cGMP, ICH, and evolving global regulatory expectations.Ā
As a member of the Central Quality leadership team, the Executive Director drives cultural transformation toward a systemic, proactive, and learningāoriented quality organization, enabling robust decisionāmaking, operational excellence, and sustained regulatory compliance across a complex, multinational environment.
Key Accountabilities
Global Business Process Ownership and Governance
Serve as Global Business Process Owner (BPO) for Quality Risk Management, with enterprise accountability for strategy, standards, performance, and continuous improvement.
Provide executive leadership and oversight for the following global process owners:
Change Control
Medical Device and Combination Product Risk
Proactive Human and Organizational Performance (HOP)
Design, own, and approve global standards, policies, and procedures ensuring alignment with cGMP, ICH, and regulatory expectations across all markets.
Ensure effective integration and alignment of risk, change, device/combination product, and human performance processes across the PQS and related business processes.
Risk and Proactive Quality Strategy
Define and execute the global Proactive Quality and Risk Management strategy, enabling early risk identification, mitigation, and prevention across operations and the supply chain.
Drive the evolution of organizational risk maturity, capability, and culture, embedding riskābased thinking into decisionāmaking at all levels.
Oversee the enterprise Quality Risk Register and development of the Operations Quality risk profile for senior leadership and management review forums.
Ensure strong linkage between Quality Risk Management and broader enterprise and operational risk management frameworks.
Proactive Human and Organizational Performance (HOP)
Provide strategic leadership to the Proactive HOP global process, ensuring effective integration of humanācentric risk mitigation approaches into quality and operational processes.
Champion learningābased, nonāpunitive approaches that strengthen human performance, reduce errorāprone conditions, and enhance system reliability.
Enable consistent application of HOP principles across sites, regions, and functions to support sustainable proactive quality outcomes.
Change Control and Device / Combination Product Risk Oversight
Provide executive governance of the global Change Control process, ensuring changes are riskāassessed, compliant, and effectively implemented across the PQS.
Oversee Medical Device and Combination Product Risk Management, ensuring appropriate risk methodologies, lifecycle oversight, and regulatory alignment across development, manufacturing, and postāmarket activities.
Ensure strong crossāfunctional collaboration with Technical, Regulatory, Safety, and Operations partners to manage complex product and process risks.
Leadership, Influence, and Stakeholder Engagement
Lead and develop a global network of BPOs, subject matter experts, and process leaders through direct, matrix, and influenceābased leadership.
Serve as a senior Quality representative in global governance forums, inspections, and regulatory interactions related to risk, change, and proactive quality.
Actively monitor internal and external signals, including audit outcomes, inspection findings, deviations, complaints, and emerging regulatory trends, to inform strategy and priorities.
Sponsor and lead transformational initiatives that leverage Lean principles, digital enablement, and innovative practices to improve process effectiveness and efficiency.
Senior leader of multiple global process owners and expert teams
Direct and indirect management of global, crossāfunctional teams
Matrix leadership across sites, regions, and functions
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Global Remit
Enterpriseāwide accountability with responsibility spanning all global markets and operating regions
Regular engagement across multiple countries and cultures
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BS/BA degree with 16+ years or MS/MA/PhD with 14+ years experience in pharmaceutical quality, manufacturing, or a related scientific discipline
Deep subject matter expertise in Quality Risk Management, with demonstrated success implementing global risk programs
Extensive experience working across multiple areas of Quality within a regulated pharmaceutical environment
Proven ability to lead through influence in complex, matrixed, multinational organizations
Strong strategic thinking, communication, and stakeholder engagement capabilities
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Experience leading largeāscale Quality or Operations transformation initiatives
Experience with Human and Organizational Performance (HOP) and Proactive Human Dependent Process Improvement
Expertise in Business Process Management, Lean, Six Sigma, or comparable continuous improvement methodologies
Experience overseeing GxP IT systems and digital enablement of Quality processes
Strong business acumen with the ability to analyze trends, assess risk, and build compelling business cases
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The salary range for this position is:
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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:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees ma
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