Executive Director – Clinical Quality Assurance

🕒 vor 1 Monat

🏄 California, Massachusetts – Remote

🏄 California – Remote 🍂 Massachusetts – Remote

💵 $265.000 - $300.000 / Jahr

⏰ Vollzeit

🔴 Experte

🔧 QA-Ingenieur (Qualitätssicherung)

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Jade Biosciences

WebsiteLinkedInAlle Stellen

11 - 50 Mitarbeiter

Gegründet 2024

🏥 Gesundheitswesen

🏭 Fertigung

🧬 Biotechnologie

Healthcare • Manufacturing • Biotechnology

Jade Biosciences ist ein Biotechnologieunternehmen im klinischen Stadium, das potenziell erstklassige Therapien entwickelt, die darauf abzielen, den Behandlungsstandard für Autoimmunerkrankungen zu revolutionieren. Sein führender Kandidat, JADE101, ist ein Antikörper, der darauf ausgelegt ist, das Zytokin APRIL (A PRoliferation-Inducing Ligand) zu hemmen und wird zur Behandlung der IgA-Nephropathie (IgAN) entwickelt. Das Unternehmen baut seine Pipeline aus Projekten in der Entdeckungsphase auf, die von Paragon Therapeutics lizenziert sind, und konzentriert sich darauf, klinische Programme voranzutreiben, um neue Behandlungen für Patienten mit Autoimmunerkrankungen bereitzustellen.

Beschreibung

• 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.

🎯 Anforderungen

• 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).

🏖️ Vorteile

• 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.