Director, Quality Risk Management

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

Job Description

The Director, Quality Risk Management (QRM) is an enterprise Quality leader responsible for defining, governing, and advancing the global strategy for Quality Risk Management across the organization. This role actively supports the Executive Director of Risk and Proactive Quality and has direct leadership accountability for the Quality Risk Management process across PDM.

This leader provides strategic direction and oversight to ensure that QRM principles, risk‑based thinking and proactive quality approaches 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 Extended Central Quality leadership team, the 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 Responsibilities and Governance

• Define and execute the global Quality Risk Management framework, with enterprise accountability for strategy, standards, performance, and continuous improvement, enabling early risk identification, mitigation, and prevention across operations and the supply chain.

• Design, own, and approve global standards, policies, procedures and training ensuring alignment with cGMP, ICH, and applicable regulatory expectations across all markets.

• Drive the evolution of organizational risk maturity, capability, and culture, embedding proactive approach to risk and risk‑based thinking into decision‑making at all levels and across GxP processes.

• Drive, implement and monitor QRM Master Plans and living Risk Assessment Portfolios across PDM.

• Ensure effective integration and alignment of Risk and Change Management processes across the PQS and related business processes.

• Ensure effective integration of Proactive HOP process and human‑centric risk mitigation approaches into quality and operational processes.

• Collaborate with the Medical Device and Combination Product (MDCP) team to support alignment and harmonization of the QRM and MDCP risk management frameworks, where applicable.

• Oversee the enterprise Quality Risk Register and development of the Operations Quality risk profile for senior leadership and management review forums.

• Ensure strong linkage and clear requirements between Quality Risk Management and broader enterprise and operational risk management frameworks.

• Serve as the Module Business Process Lead for the electronic QRM system (e.g., GVault Risk Module), with accountability for maintaining and enhancing its use across QRM activities.

• Ensure strong cross‑functional collaboration with Technical, Regulatory, Safety, and Operations partners to manage product, process, vendor and systems risks within GxP.

• Lead and actively contribute to QRM-related projects and initiatives, including process and system enhancements and continuous improvement opportunities.

• Define, implement and monitor metrics, KPIs and dashboards to assess the health and effectiveness of the QRM process.

• Partner with executive leadership, site heads and functional leaders to align QRM priorities with business objectives

Leadership, Influence, and Stakeholder Engagement

• Develop and lead a global network of Risk Leads, Risk Facilitators, Subject Matter Experts, and risk practitioners through direct, matrix, and influence‑based leadership.

• Serve as a senior Quality representative in global governance forums, inspections, and regulatory interactions related to Quality Risk Management.

• 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 QRM and Lean principles, digital enablement, and innovative practices to improve process effectiveness and efficiency.

Typical People Management Responsibility

• Senior leader of 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 12+ years or MS/MA/PhD with 10+ 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 engage effectively with stakeholders at all levels globally and lead through influence across complex, matrixed, multinational organizations

• Strong strategic thinking, communication, and stakeholder engagement capabilities

Desirable

• Experience leading large‑scale Quality or Operations transformation initiatives

• 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: $210,375.00 - $272,250.00. 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.

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