Director, Quality Risk Management

Gilead Sciences • Foster City, CA

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About The Position

The Director, Quality Risk Management (QRM) is an enterprise Quality leader responsible for defining, governing, and advancing the organization’s global QRM strategy. The role supports the Executive Director of Risk and Proactive Quality and has direct leadership accountability for the QRM process across PDM. It provides strategic direction and oversight to embed QRM principles, risk-based thinking, and proactive quality approaches throughout the Pharmaceutical Quality System (PQS) and operations.

The Director designs, implements, and sustains compliant, scalable, and efficient global processes that support early risk identification, effective 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 advances a systemic, proactive, learning-oriented quality culture and supports sound decision-making, operational excellence, and sustained regulatory compliance across a complex multinational environment.

The role has enterprise-wide accountability across global markets and operating regions, regular engagement across countries and cultures, and senior leadership of expert teams through direct, indirect, matrix, and influence-based leadership. The stated salary range is $210,375 to $272,250. The position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and company-sponsored medical, dental, vision, and life insurance plans.

Requirements

• BS/BA degree and 12 or more years of experience in pharmaceutical quality, manufacturing, or a related scientific discipline; or MS/MA/PhD and 10 or more years of experience in those fields.
• Deep subject matter expertise in Quality Risk Management, with demonstrated success implementing global risk programs.
• Extensive experience across multiple areas of Quality in a regulated pharmaceutical environment.
• Proven ability to engage stakeholders at all levels globally and lead through influence in complex, matrixed, multinational organizations.
• Strong strategic thinking, communication, and stakeholder engagement capabilities.

Nice To Haves

• 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 and ability to analyze trends, assess risk, and build compelling business cases.

Responsibilities

• Define and execute the global Quality Risk Management framework, with enterprise accountability for strategy, standards, performance, and continuous improvement across operations and the supply chain.
• Design, own, and approve global QRM standards, policies, procedures, and training aligned with cGMP, ICH, and applicable regulatory expectations.
• Advance organizational risk maturity, capability, and culture by embedding proactive risk approaches and risk-based thinking into decision-making and GxP processes.
• Drive, implement, and monitor QRM Master Plans and living Risk Assessment Portfolios across PDM.
• Integrate and align Risk and Change Management processes across the PQS and related business processes.
• Integrate the Proactive HOP process and human-centric risk mitigation approaches into quality and operational processes.
• Collaborate with the Medical Device and Combination Product team to align and harmonize QRM and MDCP risk management frameworks where applicable.
• Oversee the enterprise Quality Risk Register and develop the Operations Quality risk profile for senior leadership and management review forums.
• Maintain strong linkage and clear requirements between QRM and broader enterprise and operational risk management frameworks.
• Serve as Module Business Process Lead for the electronic QRM system, such as the GVault Risk Module, and maintain and enhance its use across QRM activities.
• Collaborate with Technical, Regulatory, Safety, and Operations partners to manage product, process, vendor, and systems risks within GxP.
• Lead and 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 QRM process health and effectiveness.
• Partner with executive leadership, site heads, and functional leaders to align QRM priorities with business objectives.
• Develop and lead a global network of Risk Leads, Risk Facilitators, Subject Matter Experts, and risk practitioners through direct, matrix, and influence-based leadership.
• Represent Quality in global governance forums, inspections, and regulatory interactions related to QRM.
• 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 using QRM and Lean principles, digital enablement, and innovative practices to improve process effectiveness and efficiency.
• Provide senior leadership to expert teams and direct and indirect management of global, cross-functional teams, including matrix leadership across sites, regions, and functions.

Benefits

• Potential eligibility for a discretionary annual bonus.
• Potential eligibility for discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Director