Vice President – Quality

This is a fully remote position, open to applicants in Washington.

📋 Description

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

• Formulate and implement a scalable, phase-appropriate Quality strategy that supports late-stage clinical development, regulatory submissions, commercial readiness, and lifecycle management.

• Take ownership of the architecture, execution, effectiveness, and expansion of the pharmaceutical Quality Management System and Quality Risk Management framework.

• Ensure adherence to global GxP requirements, encompassing GMP, GCP, and GVP.

• Lead efforts for inspection readiness, audits, quality governance, and prompt resolution of observations.

• Establish and manage the Quality governance model for CMOs, CDMOs, CROs, contract laboratories, suppliers, and other GxP partners.

• Supervise qualification, quality agreements, audits, performance monitoring, risk escalation, change control, investigations, validation, and supply continuity.

• Provide Quality leadership throughout 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 nurture a high-performing Quality organization, including leadership of the Senior Director of Quality Assurance.

• Promote 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.

• Offer risk-based guidance to executive leadership and the Board.

⛳️ Requirements

• A Bachelor’s degree in a scientific discipline is required; an advanced degree (MS, PhD, PharmD, or equivalent) is preferred.

• A minimum of 15 years of progressive Quality experience in biotechnology or pharmaceutical companies.

• Significant leadership experience in lean, resource-constrained environments.

• Proven track record in leading Quality strategy through late-stage clinical development, regulatory submissions, and commercial readiness, including first product launches.

• Direct experience with small-molecule products; recent small-molecule experience is preferred.

• Extensive knowledge and practical application of FDA, EMA, ICH, GMP, GCP, and GVP requirements, including ICH Q9(R1) and ICH Q10 principles.

• Experience in designing, implementing, or significantly transforming pharmaceutical QMS and QRM frameworks in organizations lacking mature commercial Quality systems.

• Proven experience leading FDA and international regulatory inspections and liaising with global health authorities.

• Experience overseeing Quality in an outsourced development and manufacturing model, including CMOs, CDMOs, CROs, and other GxP vendors.

• Demonstrated ability to build and scale Quality organizations, lead through influence, and provide clear, risk-based recommendations to executive leadership and Boards.

• Occasional domestic travel is required; international travel may also be necessary.

🏝️ Benefits

• 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, in addition to 11 paid holidays and a company-wide closure during 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.

• Eligibility for annual bonuses.

• Equity eligibility.