Position Summary
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 Quality Assurance, while fostering accountability, collaboration, and continuous improvement.
Qualifications
- 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, including significant leadership responsibility in lean, resource-constrained environments.
- Demonstrated experience leading Quality strategy through late-stage clinical development, regulatory submissions, and commercial readiness, including first product launches, with 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.
- Demonstrated 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 & Perks
We offer a comprehensive benefits package designed to support our employees and their families, including:
- 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
- Generous PTO: 25 days accrued annually, plus 11 paid holidays and a company-wide closure the last week of December
- Life & disability coverage: Basic Life, AD&D, Short-Term and Long-Term Disability fully paid by Leona, with voluntary options available
- Flexible Spending Accounts: Health and Dependent Care FSA options
- Professional development: up to $6,000 annually reimbursed for job-relevant, manager-approved education
Compensation
The base salary range for this position is $320,000-$350,000. This role may be eligible for an annual bonus and equity, in addition to our full benefits package outlined above. Actual compensation will be determined based on factors including relevant experience, skill set, education, and internal pay equity.
