Quality Assurance Manager

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🕒 Março 9

🏄 California – Remoto

🏄 California – Remote

💵 $85.000 - $125.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🔧 Engenheiro de QA (Qualidade de Software)

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Vanguard Clinical, Inc.

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2012

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

Biotechnology • Healthcare Insurance • Pharmaceuticals

A Vanguard Clinical, Inc. é uma Organização de Pesquisa por Contrato (CRO) e Provedora de Serviços Funcionais (FSP) boutique que se especializa em oferecer serviços personalizados para a execução de ensaios clínicos. Com foco na flexibilidade, transparência e serviço de alta qualidade, a Vanguard Clinical faz parceria com empresas patrocinadoras para gerenciar seus projetos de desenvolvimento clínico de forma eficaz. A empresa enfatiza o cuidado no manejo dos ativos dos clientes, o cumprimento regulatório e a gestão de projetos ideal, oferecendo uma gama de serviços desde monitoramento clínico e gerenciamento de dados até recrutamento de pacientes e garantia de qualidade.

Descrição

• Provides independent quality oversight of internal and external clinical trial activities, records, and processes to ensure compliance with FDA regulations, ICH-GCP, internal SOPs, and other applicable regulatory requirements. • Supports quality objectives across the organization and contributes to achieving departmental and company goals. • Maintains current knowledge of applicable GxP requirements and regulatory developments and communicates relevant impacts to QA leadership and stakeholders. • Supports the implementation, maintenance, and ongoing oversight of the Quality Management System (QMS). • Develops, reviews, and maintains SOPs and quality documentation to ensure compliance with applicable regulatory requirements (ICH-GCP, FDA CFR, etc.). • Provides client-facing Quality Assurance support, including development of quality documentation (e.g., SOPs, plans) and regulatory compliance guidance. • Establishes and maintains appropriate quality standards, parameters, and controls across clinical programs and quality processes. • Ensures ongoing compliance with applicable federal, state, local, and organizational regulations, guidelines, and policies. • Implements and supports Clinical Quality Assurance plans aligned with GCP standards, internal policies, and procedures. • Leads and supports inspection and audit readiness activities, including preparation, coordination, and participation in regulatory agency inspections. • Plans, conducts, and/or supports qualification, routine, and for-cause audits, and participates in the evaluation, qualification, and ongoing oversight of clinical vendors in accordance with company SOPs. • Oversees the management, tracking, and effectiveness of audit observations and CAPAs, including root cause analysis, trending, and escalation of systemic quality issues. • Evaluates quality trends and metrics to identify risks, support continuous improvement, and informs QA reporting to management. • Provides QA guidance to cross-functional teams through participation in study team meetings and interpretation of current regulatory requirements and best practices. • Conducts or supports QA review of clinical and regulatory documents, including protocols, Investigator Brochures, Clinical Study Reports, and integrated summaries, as applicable. • Supports the development and delivery of training materials and provides GCP and SOP-related training to internal stakeholders. • Collaborates with clinical teams to assess and investigate temperature excursions, deviations, and product complaints reported from clinical sites. • Participates in QA budget planning and resource forecasting activities. • Develops, monitors, and reports GCP quality metrics to support consistent quality performance across the organization. • Performs other duties and special projects as required.

🎯 Requisitos

• 4 to 7+ years of experience in a related field required with supervisory experience a plus • Highly proficient with Office 365 (Outlook calendar, email, Excel, PowerPoint, and Word are a must) • Excellent communication skills • Acute attention to detail • Must be highly organized and able to multi-task prioritizing simultaneous tasks • Maintain confidentiality • Exercise independent judgment and discretion • Effectively work cross-functionally across the organization and externally

🏖️ Benefícios

• health insurance • 401k retirement plan • paid days off • annual performance bonus