Executive Director, Risk and Proactive 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

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 riskbased thinking proactive quality practices and humancentric 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.
As a member of the Central Quality leadership team the Executive Director drives cultural transformation toward a systemic proactive and learningoriented quality organization enabling robust decisionmaking 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 riskbased thinking into decisionmaking 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 humancentric risk mitigation approaches into quality and operational processes.

• Champion learningbased nonpunitive approaches that strengthen human performance reduce errorprone 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 riskassessed 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 postmarket activities.

• Ensure strong crossfunctional 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 influencebased 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.

Typical People Management Responsibility

• Senior leader of multiple global process owners and expert teams

• Direct and indirect management of global crossfunctional teams

• Matrix leadership across sites regions and functions
  

Global Remit

• Enterprisewide accountability with responsibility spanning all global markets and operating regions

• Regular engagement across multiple countries and cultures
  

Education Qualifications Skills and Experience

Essential

• 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
  

Desirable

• Experience leading largescale 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
  

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:

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