Executive Director – Clinical Quality Assurance

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🕒 Junho 26

🏄 California, Massachusetts – Remoto

🏄 California – Remote 🍂 Massachusetts – Remote

💵 $265.000 - $300.000 / ano

⏰ Tempo Integral

🔴 Especialista

🔧 Engenheiro de QA (Qualidade de Software)

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Jade Biosciences

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2024

🏥 Saúde

🏭 Manufatura

🧬 Biotecnologia

Healthcare • Manufacturing • Biotechnology

A Jade Biosciences é uma empresa de biotecnologia em fase clínica, desenvolvendo potencialmente terapias de melhor da categoria, voltadas para transformar o padrão de cuidado para doenças autoimunes. Seu principal candidato, o JADE101, é um anticorpo projetado para inibir a citocina APRIL (A Proliferação-Induzindo Ligante) e está sendo desenvolvido para o tratamento da nefropatia por IgA (IgAN). A empresa constrói seu pipeline a partir de ativos em fase de descoberta licenciados pela Paragon Therapeutics e está focada em avançar programas clínicos para oferecer novos tratamentos para pacientes com condições autoimunes.

Descrição

• Provide hands on clinical QA oversight and review of protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents. • Provide coaching, Quality decisions and be Quality approver to study teams on protocol deviations, vendor oversight, CAPAs, and issue management. • Act as the primary GCP/GPvP/GLP QA subject matter expert and point of contact for all related matters and issues. • Represent Quality on project teams, service providers and CROs operational meetings, and QA to QA meetings. • Oversee ongoing clinical programs to ensure they are risk‑based, fit‑for‑purpose and in compliance with applicable regulations and guidelines across all phases of development. • Review and approve (as appropriate) procedures, service provider quality agreements, qualification and onboarding forms and regulatory filings. • Develop, implement and execute a risk-based audit strategy and detailed plans for clinical and non-clinical studies. • Establish and maintain GCP/GPvP/GLP QA programs, policies and procedures. • Work collaboratively with the internal Clinical Operations Team and Development Teams to provide leadership and guidance to support study execution, data integrity, and regulatory compliance. • Identify and assess compliance risk and develop and implement risk mitigation measures. • Lead the identification, investigation (root cause analysis), and resolution of quality issues through a robust investigation and CAPA process. • Contribute to building a strong quality culture within the organization. • Ensure the timely and effective follow up of all identified or assigned quality issues. • Direct and/or deliver yearly training for internal staff as needed. • Work closely with Development, Clinical Operations, and other functions/departments to drive inspection readiness and support regulatory interactions. • Champion continuous improvement and simplification across clinical quality systems. • Prepare KPIs, metrics and analysis and present status updates as needed. • Provide leadership in inspection preparedness to clinical sites and service providers for regulatory government agencies. • Stay current on global regulations, industry trends, and best practices to ensure continuous improvement and innovation within the QA function. • Apply risk‑based thinking to identify the quality activities that meaningfully influence study outcomes, rather than defaulting to checklists or bureaucracy. • Understand when to escalate, when to intervene, and when to let teams move forward without over engineering processes. • Provide clear, concise guidance that helps teams stay focused, aligned, and inspection ready.

🎯 Requisitos

• Bachelors + 17 or Masters + 15 or PhD + 10 years of related experience. • Extensive expertise in GCP, GPvP, GLP and ICH clinical requirements, clinical development and methodologies of clinical studies. • Successful track record of translation and implementation of clinical requirements into operational execution. • Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices. • A successful track record of working with service providers and CROs. • Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. • Ability to tactically and strategically execute the day-to-day operations to support clinical trials and clinical and non-clinical development activities. • Knowledge of Quality Management Systems; experience in building, implementing and managing quality systems in the pharmaceutical industry. • Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs). • Effective communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies. • Strong organizational skills and the ability to participate effectively cross-functionally. • A self-starter and a team player who thrives in a fast-paced dynamic team environment. • Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others. Prior management experience is required. • Previous experience in successfully leading assigned activities within cross-functional teams. • Proficiency in using SharePoint, Veeva and Microsoft Office applications required (MS Outlook, MS Word, MS Excel, MS PowerPoint).

🏖️ Benefícios

• Jade Biosciences participates in E-Verify as part of the I-9 verification of authorization to work in the United States. • Jade Biosciences is proud to be an Equal Opportunity employer.