Executive Director, Risk and Proactive Quality

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s 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 we’re 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 risk‑based thinking, proactive quality practices, and human‑centric 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 learning‑oriented quality organization, enabling robust decision‑making, 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 risk‑based thinking into decision‑making 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 human‑centric risk mitigation approaches into quality and operational processes.

• Champion learning‑based, non‑punitive approaches that strengthen human performance, reduce error‑prone 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 risk‑assessed, 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 post‑market activities.

• Ensure strong cross‑functional 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 influence‑based 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, cross‑functional teams

• Matrix leadership across sites, regions, and functions
   

Global Remit

• Enterprise‑wide 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 large‑scale 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:

Other US Locations: $255,425.00 - $330,550.00.

 

Bay Area: $281,010.00 - $363,660.00.

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:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees ma