Vice President – Quality

LeonaBio

. Serve as the executive leader for LeonaBio’s Quality function, providing strategic direction across quality systems, clinical development, manufacturing, and regulatory compliance .

Posted 9/15/2026full-timeRemote • Washington • United StatesLead💰 $320,000 - $350,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Quality Management Systems and regulatory compliance within the biotechnology and pharmaceutical sectors, with a strong focus on late-stage clinical development and commercial readiness. Proven leadership in building high-performing Quality organizations and managing GxP compliance across various partners and vendors.

Highest-signal resume keywords

Quality Management System (QMS) ImplementationRegulatory Compliance (GMP, GCP, GVP)Leadership in Quality StrategySmall-Molecule Drug DevelopmentRisk-Based Decision Making

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Risk Management (QRM)Regulatory SubmissionsProcess ValidationAnalytical MethodsChange ControlQuality AuditsInspection ReadinessPerformance MonitoringLifecycle ManagementTechnology Transfer

Soft Skills

CollaborationAccountabilityContinuous ImprovementInfluenceLeadership

Industry Keywords

BiotechnologyPharmaceuticalFDAEMAICHGxPLean EnvironmentsCROsCDMOsCMOs

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Bachelor’s degree in a scientific discipline required; advanced degree (MS, PhD, PharmD, or equivalent) preferred
15+ years of progressive Quality experience in biotechnology or pharmaceutical companies
Significant leadership responsibility in lean, resource-constrained environments
Experience leading Quality strategy through late-stage clinical development, regulatory submissions, and commercial readiness, including first product launches
Direct small-molecule experience; recent small-molecule experience preferred
Deep knowledge and practical application of FDA, EMA, ICH, GMP, GCP, and GVP requirements, including ICH Q9(R1) and ICH Q10 principles
Experience personally designing, implementing, or materially transforming pharmaceutical QMS and QRM frameworks in organizations without mature commercial Quality systems
Experience leading FDA and international regulatory inspections and interacting with global health authorities
Experience overseeing Quality in an outsourced development and manufacturing model, including CMOs, CDMOs, CROs, and other GxP vendors
Proven ability to build and scale Quality organizations, lead through influence, and provide clear, risk-based recommendations to executive leadership and Boards
Occasional domestic travel required; international travel may be required

Benefits

Comp & perks

Medical, dental, and vision coverage: Leona covers 100% of employee premiums and 80% of dependent premiums (Premera Blue Cross PPO, Delta Dental, VSP)
401(k) with employer match: immediate eligibility, with Leona matching 100% of employee contributions up to 4% of salary
25 days accrued annually, plus 11 paid holidays and a company-wide closure the last week of December
Basic Life, AD&D, Short-Term and Long-Term Disability fully paid by Leona, with voluntary options available
Health and Dependent Care FSA options
Up to $6,000 annually reimbursed for job-relevant, manager-approved education
Annual bonus eligibility
Equity eligibility