Director, Clinical Quality Assurance – CQA

🕒 Abril 22

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $205.000 - $235.000 / ano

⏰ Tempo Integral

🔴 Especialista

🔧 Engenheiro de QA (Qualidade de Software)

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4D Molecular Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

A 4DMT é uma empresa biofarmacêutica em fase clínica que inventa e desenvolve produtos inovadores para desbloquear todo o potencial da medicina genética no tratamento de doenças de grande mercado e doenças raras. Nossa plataforma de descoberta de vetores, a Therapeutic Vector Evolution, aproveita o poder da evolução dirigida, uma tecnologia vencedora do Prêmio Nobel, com aproximadamente um bilhão de sequências derivadas de capsídeos sintéticos de AAV para inventar vetores personalizados e evoluídos com perfis terapêuticos aprimorados em comparação com vetores do tipo selvagem. Nosso motor de design, desenvolvimento e manufatura de produtos nos capacita a criar com eficiência nosso valioso e diversificado pipeline de produtos. Esta combinação de inovação ousada e execução implacável dá à 4DMT a capacidade de revolucionar os medicamentos genéticos e buscar terapias potencialmente curativas. Construímos um portfólio profundo de candidatos a produtos de medicina genética, com cinco candidatos a produtos em ensaios clínicos para sete populações de pacientes.

Descrição

• Provide Quality oversight for multiple 4DMT Clinical Studies, including the following study-specific activities: • Develop and implement Clinical Study Quality Plans for specific 4DMT clinical studies, focused on ensuring subject safety/rights, study data integrity, and GCP compliance. • Provide guidance and support to clinical study teams, including via attendance at Study team meetings and via investigation and management of Clinical Study Quality Events. • Ensure principles of Risk Management are applied to the Clinical Study per ICH E6. • Identify, communicate, and escalate significant incidents of GCP non-compliance and follow to resolution, acting at all times with an appropriate sense of urgency. • Plan, perform, and/or oversee GCP Compliance audits of high-risk clinical vendors/sites, including clinical investigator sites. • Ensure audit findings are communicated to audit stakeholders and collaborate with auditees and vendors to track, review, approve, and assess the adequacy of CAPAs. • Perform Clinical Document reviews, ensuring the quality, accuracy and completeness of various documents, including as applicable Clinical Protocols, IBs, DSURs, Module 2.6 Tabulated and Written Summaries, and Integrated Summaries.

🎯 Requisitos

• S./B.A. degree in a science or related life science field or equivalent; advanced scientific degree preferred. • 10+ years of experience or advanced degree with 7+ years of experience within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development / Operations within the Biotech or similar Industry • Proven experience with GCP Quality Management Systems, quality support, and quality oversight of global clinical trials • Minimum of 4 years of significant experience in clinical quality assurance, including experience performing/supporting GCP audits and overseeing global clinical trials, including in APAC. • Extensive practical experience and understanding of clinical quality assurance as applied throughout the clinical development life-cycle • (Optional) 5+ years of management experience or other specific work experience. • In-depth understanding of GCP requirements for investigational products. • Excellent communication skills, both oral and written. • Excellent interpersonal skills, collaborative approach essential. • Comfortable in a fast-paced small company environment with minimal direction and able to adjust to workload based upon changing priorities.

🏖️ Benefícios

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options