Vice President – Quality

🕒 Setembro 15

☕ Washington – Remoto

☕ Washington – Remote

💵 $320.000 - $350.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

👻 Score fantasma 2%

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LeonaBio

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🧬 Biotecnologia

💊 Farmacêutico

🏥 Saúde

💰 $103.500.000 Post IPO equity em 2021-02

Biotechnology • Pharmaceuticals • Healthcare

A LeonaBio é uma empresa biofarmacêutica em estágio clínico que se concentra no desenvolvimento de novas terapias de pequenas moléculas para doenças graves com opções de tratamento limitadas. Seus principais candidatos incluem o lasofoxifeno e o brelgometon (ATH-1105), e a empresa realiza ensaios clínicos para avaliar a segurança e eficácia como parte de sua missão de melhorar o cuidado ao paciente. A LeonaBio está ativa em assuntos médicos e engajamento de pacientes e recentemente apresentou o ATH-1105 em um congresso de desenvolvimento de medicamentos para ELA, indicando envolvimento na pesquisa de doenças neurodegenerativas.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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