Vice President, Quality

About LeonaBio: LeonaBio, Inc., headquartered in the Seattle, Washington area, is a clinical-stage biopharmaceutical company developing novel therapeutics for high unmet medical needs, including treatment-resistant metastatic breast cancer and amyotrophic lateral sclerosis (ALS). Our lead programs, lasofoxifene and brelgometon, are novel small-molecule therapies with the potential to address devastating diseases where current treatment options are limited or ineffective. We are committed to scientific excellence and patient-centered innovation as we advance meaningful new therapies for patients.

About the role

LeonaBio is seeking an experienced, hands-on Vice President, Quality to lead the company’s Quality function through the transition from late-stage clinical development to regulatory approval, commercial launch, and lifecycle management. This executive will be responsible for designing, implementing, and scaling a phase-appropriate Quality Management System and Quality Risk Management framework that meets global regulatory requirements, reflects the company’s size and stage, and supports commercial operations. The ideal candidate has direct leadership experience in a biotechnology company developing and commercializing small-molecule products, with a demonstrated track record of building or materially transforming Quality systems and governance. This individual will integrate product quality, patient, compliance, supply, vendor, inspection, and commercialization risks into enterprise decision-making and provide clear, risk-based guidance to executive leadership and the Board. The Vice President, Quality will foster a practical culture of quality that supports timely business decisions, inspection readiness, reliable product supply, and sustainable commercial operations.

Responsibilities

• 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 that supports late-stage clinical development, regulatory submissions, commercial readiness, and lifecycle management.
• Own the architecture, implementation, effectiveness, and scaling of the company’s pharmaceutical Quality Management System (QMS) and Quality Risk Management (QRM) framework, ensuring inspection readiness and alignment with a lean, outsourced operating model.
• Ensure compliance with applicable global GxP requirements, including GMP, GCP, and GVP, while maintaining a pragmatic, risk-based approach to Quality. 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, including 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