Vice President – Quality

🔥 12 hours ago

☕ Washington – Remote

☕ Washington – Remote

💵 $320k - $350k / year

⏰ Full Time

🔴 Lead

👔 Vice President

👻 Ghost score 1%

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LeonaBio

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

💰 $103.5M Post IPO equity on 2021-02

Biotechnology • Pharmaceuticals • Healthcare

LeonaBio is a clinical-stage biopharmaceutical company focused on developing novel small-molecule therapies for serious diseases with limited treatment options. Its lead candidates include lasofoxifene and brelgometon (ATH-1105), and the company conducts clinical trials to evaluate safety and efficacy as part of its mission to improve patient care. LeonaBio is active in medical affairs and patient outreach and has recently presented ATH-1105 at an ALS drug development summit, indicating involvement in neurodegenerative disease research.

📋 Description

• 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

• 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

• 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