Vice President, Quality

LeonaBio, Inc.; Bothell (WA); On-site; USD 320,000 - 350,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with employer match

Generous PTO

Life & disability coverage

Flexible Spending Accounts

Professional development

Job summary

LeonaBio, Inc., headquartered in the Seattle area, seeks a hands-on Vice President, Quality to lead the Quality function through late-stage development to regulatory approval and launch.

The ideal candidate will build and scale a phase-appropriate QMS and QRM, integrate product quality with compliance, supply, and vendor risk, and report to the executive leadership and Board.

Qualifications

• Bachelor’s degree in a scientific discipline required; advanced degree preferred.
• 15+ years of progressive Quality experience in biotech/pharma.
• Experience leading QMS and QRM implementations for late-stage development.
• Deep knowledge of FDA, EMA, ICH, GMP, GCP, GVP requirements.
• Experience designing or transforming pharmaceutical QMS and QRM.
• Experience leading FDA and international regulatory inspections.
• Ability to lead outsourced development and manufacturing quality.
• Travel required domestically and internationally.

Responsibilities

• Lead LeonaBio’s Quality function across QA, regulatory, manufacturing, and compliance.
• Develop scalable, phase-appropriate Quality strategy for late-stage to launch.
• Own QMS and QRM architecture, ensuring inspection readiness with lean outsourcing.
• Ensure global GxP compliance and lead inspections/audits.
• Govern CMOs/CDMOs/CROs, quality agreements, audits, and risk monitoring.
• Provide quality leadership for drug substance, product development, transfer, and launch.
• Build and mentor a high-performing Quality organization.

Skills

Quality leadership

Strategic planning

Regulatory compliance

QMS implementation

Risk management

Cross-functional

Inspection readiness

Vendor management

Executive communication

Small-molecule experience

Education

Bachelor's degree in science

Advanced degree preferred

Job description

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.

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.

LeonaBio is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline and termination.