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Director, Global Process Owner (GPO) of Event Management & CAPA

Gilead Sciences
September 09, 2026
Full-time
Remote friendly (San Francisco Bay Area)
Worldwide
Operations
Role: Serve as the Global Business Process Owner for Event Management & CAPA, focusing on deviations and quality event processes within Gilead's regulated environment. Responsibilities: define and implement global process strategy, establish standards, ensure compliance with regulatory and quality standards, drive process standardization, monitor performance metrics, lead continuous improvement initiatives, and support audits and inspections. Also, lead process governance, stakeholder engagement, and digital transformation efforts to enhance process maturity and efficiency. Qualifications: Bachelor's in Life Sciences, Engineering, or related; 12+ years in pharmaceutical/biotech quality systems with expertise in deviation management, CAPA, investigations, and regulatory compliance; advanced degree preferred. Preferred skills include global process leadership, cross-functional project management, and problem-solving certifications (e.g., Lean Six Sigma). HighValue: Quality systems leadership, deviation & CAPA management, regulatory compliance (FDA, EMA, ICH), GxP standards, process standardization, digital transformation, and cross-functional collaboration across R&D, manufacturing, and quality functions. Work setup: Not specified; focus on global enterprise process ownership.