Associate Director, Clinical Quality Assurance

🕒 4 dias atrás

🏄 California – Remoto

🏄 California – Remote

💵 $172.000 - $195.000 / ano

⏰ Tempo Integral

🟠 Sênior

🔧 Engenheiro de QA (Qualidade de Software)

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Artiva Biotherapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🧬 Biotecnologia

🏥 Saúde

💊 Farmacêutico

💰 Series B em 2021-02

Biotechnology • Healthcare • Pharmaceuticals

A Artiva Biotherapeutics é uma empresa de imunoterapia com capacidade de produzir terapias celulares NK alogênicas prontas para uso em larga escala. Nossa missão é desenvolver terapias celulares eficazes, seguras e acessíveis para pacientes com doenças autoimunes devastadoras e cânceres. Nosso principal programa, o AlloNK®, é um candidato a terapia celular NK alogênica, não modificado geneticamente, projetado para melhorar a atividade de anticorpos monoclonais ou ativadores de células NK. O AlloNK está atualmente em ensaios clínicos em combinação com rituximabe para o tratamento de lúpus eritematoso sistêmico (LES) em pacientes com nefrite lúpica ativa e para o tratamento de Linfoma Não-Hodgkin, bem como em combinação com o ativador de células inatas AFM13 da Affimed para o tratamento de pacientes com linfomas CD30-positivos recidivantes/refratários.

Descrição

• Serve as the Clinical QA lead for assigned clinical programs and provide quality oversight across all phases of clinical development. • Develop, implement, and conduct risk-based GCP quality oversight strategies. • Lead investigations of significant GCP quality and compliance events, including CAPA development and effectiveness oversight. • Plan, conduct, and manage contract auditors for routine and for-cause audits of clinical investigator sites, CROs, and vendors. • Assess and communicate audit findings' impact on sponsor oversight, subject safety, data integrity, protocol compliance, and internal processes. • Maintain required documentation and quality records. • Lead inspection readiness activities and support regulatory authority inspections. • Collaborate with internal teams to ensure quality compliance across clinical development. • Define and implement review strategies for key regulatory documents associated with submissions. • Lead development and implementation of clinical quality procedures with Clinical Development. • Identify GCP compliance risks and develop mitigation actions. • Monitor emerging regulations and communicate relevant changes. • Provide QA consultation and participate in risk-based sponsor oversight activities. • Define, support, and deliver GCP training for Clinical Operations staff. • Define and present quality metrics and trend analyses. • Participate in interviewing and hiring Clinical Quality Assurance staff.

🎯 Requisitos

• BS or BA in a scientific field. • 8+ years of clinical and/or QA experience in biologics or pharma. • 4+ years of Clinical QA experience. • Knowledge and hands-on experience with regulatory inspections and clinical investigator site, vendor, and internal audits. • Thorough knowledge of current Good Clinical Practices and Good Clinical Laboratory Practices for all phases of cell therapy product human clinical trials. • Expert-level understanding of CLIA and CAP. • Knowledge of ICH, GCP, GCLP, data privacy, and other applicable pharmaceutical/biopharma regulations and requirements. • Sound scientific training and communications knowledge. • Expert knowledge of quality regulations, current industry practices, and their interpretation and application. • Computer skills required to operate Microsoft Word, Project, and Excel. • Preferred: experience in small or emerging biotechnology companies. • Familiarity with global pharmacovigilance regulations and quality systems preferred. • Experience supporting or overseeing GVP quality activities, safety vendors, or pharmacovigilance processes preferred. • Demonstrated understanding of the interface between GCP and GVP requirements preferred.

🏖️ Benefícios

• A beautiful facility • An entrepreneurial, highly collaborative, and innovative environment • Medical, Dental, and Vision • Group Life Insurance • Long Term Disability (LTD) • 401(k) Retirement Plan • Employee Assistance Program (EAP) • Flexible Spending Account (FSA) • Paid Time Off (PTO) • Company paid holidays, including the year-end holiday week • Recognition program, Bonus.ly, where you can trade in points earned for things you want