Director, Quality Control – Stability and Reference Materials

Gilead Sciences

Director, Quality Control overseeing global strategy and governance of Stability Program Management and Reference Standards at Gilead.

Posted 5/13/2026full-timeFoster City • California • 🇺🇸 United StatesLead💰 $210,375 - $272,250 per yearWebsite

About the role

Key responsibilities & impact

Accountable for the global strategy, governance, and long-term performance of Stability Program Management and Reference Standards & Analytical Controls across Gilead’s development and commercial portfolio.
Define and own the enterprise-wide strategy, vision, and multi‑year roadmap for Stability Program Management and Reference Standards & Analytical Controls.
Design, own, and maintain global policies, standards, procedures, governance models, and decision frameworks.
Serve as the final global authority for interpretation, application, and risk-based decision-making related to Stability and Reference Materials processes.
Oversee and direct global implementation strategies for new or revised processes.
Sponsor development of training frameworks, role-based enablement, certification expectations, and change management approaches.
Define, monitor, and govern enterprise-level KPIs and performance indicators for Stability and Reference Materials.
Act as the global process authority during regulatory inspections and health authority interactions.
Lead continuous improvement and change management, applying Lean principles to process design and execution.
Lead and sustain a global, matrixed network of senior SMEs and functional leaders, influencing without direct authority.

Requirements

What you’ll need

Bachelor’s degree in a Life Sciences, Chemistry, Engineering, or related field and 12+ years experience in Quality Control, Analytical Development, Stability, or Quality Systems within regulated environments.
OR Masters' Degree in a Life Sciences, Chemistry, Engineering, or related field and 10 + Years' Experience in Quality Control, Analytical Development, Stability, or Quality Systems within regulated environments.
OR PhD in a Life Sciences, Chemistry, Engineering, or related field and 8 + Years' Experience in Quality Control, Analytical Development, Stability, or Quality Systems within regulated environments.
Demonstrated success operating at a strategic, enterprise level with global accountability.
Recognized expertise in ICH stability expectations and reference standard governance.
Proven experience advising senior leadership and representing processes during regulatory inspections.
Prior experience as a Global Business Process Owner, enterprise Quality lead, or equivalent director-level role preferred.
Experience leading enterprise transformation or digital Quality initiatives preferred.
Experience with global digital quality systems (LIMS, QMS, statistical trending platforms) preferred.

Benefits

Comp & perks

company-sponsored medical, dental, vision, and life insurance plans*
discretionary annual bonus
discretionary stock-based long-term incentives (eligibility may vary based on role)
paid time off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality ControlAnalytical DevelopmentStabilityQuality SystemsLean principlesKPI monitoringRisk-based decision-makingProcess designChange managementRegulatory compliance

Soft Skills

Strategic thinkingLeadershipInfluencing without authorityCommunicationCollaborationTraining developmentGovernanceContinuous improvementDecision-makingProblem-solving