LeonaBio

Vice President

• Serve as the executive leader for LeonaBio’s Quality function, providing strategic direction across quality systems, clinical development, manufacturing, and regulatory compliance
• Develop and execute a scalable, phase-appropriate Quality strategy supporting late-stage clinical development, regulatory submissions, commercial readiness, and lifecycle management
• Own the architecture, implementation, effectiveness, and scaling of the pharmaceutical Quality Management System and Quality Risk Management framework
• Ensure compliance with global GxP requirements, including GMP, GCP, and GVP
• Lead inspection readiness, audits, quality governance, and timely resolution of observations
• Establish and oversee the Quality governance model for CMOs, CDMOs, CROs, contract laboratories, suppliers, and other GxP partners
• Oversee qualification, quality agreements, audits, performance monitoring, risk escalation, change control, investigations, validation, and supply continuity
• Provide Quality leadership across small-molecule drug substance and drug product development, technology transfer, process validation and PPQ, analytical methods, stability, specifications, packaging, commercial launch, and post-approval lifecycle management
• Build and develop a high-performing Quality organization, including leadership of the Senior Director of Quality Assurance
• Foster accountability, collaboration, continuous improvement, inspection readiness, reliable product supply, and sustainable commercial operations
• Integrate product quality, patient, compliance, supply, vendor, inspection, and commercialization risks into enterprise decision-making
• Provide risk-based guidance to executive leadership and the Board

Vice President – Quality