Senior Clinical Quality Assurance Associate

🕒 Julho 22

🏄 California, Colorado, +7 estados a mais – Remoto

🏄 California – Remote ⛰️ Colorado – Remote 🏛️ District of Columbia – Remote 🌺 Hawaii – Remote 🌽 Illinois – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote 🍂 Massachusetts – Remote ☕ Washington – Remote

⏰ Tempo Integral

🟠 Sênior

🔧 Engenheiro de QA (Qualidade de Software)

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WEP Clinical

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2008

💼 Consultoria

📦 Logística

💊 Farmacêutico

Consulting • Logistics • Pharmaceuticals

A WEP Clinical é uma Provedora de Serviços Farmacêuticos que se especializa em Programas de Desenvolvimento de Medicamentos, Soluções de Acesso a Tratamentos e Acesso ao Mercado e Comercialização. A empresa foca em fornecer suporte crítico ao longo de todo o percurso de desenvolvimento e comercialização de medicamentos, ajudando patrocinadores a avançarem com suas medicações e a melhorarem o acesso dos pacientes. A WEP Clinical oferece serviços como serviços de ensaios clínicos, programas de acesso expandido, programas de pacientes nomeados pós-aprovação e consultoria de acesso ao mercado, garantindo que as terapias tão necessárias alcancem pacientes em todo o mundo.

Descrição

• Responsible for the leadership and operational execution of the site quality assurance function regarding the distribution and manufacturing (secondary packaging & labelling) activities. • Oversee and drive day-to-day site operations, driving compliance to regulatory Good Manufacturing and Distribution Practice standards and operational improvements. • Act as a primary expert and interface between supply chain and logistics, project management and other departments to drive delivery of client solutions with respects to Post Approval Named Patient/Expanded Access Program and Clinical Trial supply service lines for the site.

🎯 Requisitos

• Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration) • 3 to 5 years of experience in a quality-related role within a CRO, pharmaceutical, biotechnology, or healthcare organization • Experience supporting global clinical trials and decentralized clinical trial activities • Experience supporting Sponsor audits, regulatory inspections, internal audits, and/or supplier audits • Practical experience with quality investigations, CAPAs, root cause analysis, quality risk assessments, and continuous improvement • Experience with eQMS, eTMF, Microsoft Office, and quality management software applications • Working knowledge of GCP regulations and global regulatory expectations, including ICH E6(R3), FDA, EU Clinical Trial Regulation, MHRA, GDPR where applicable, and related requirements • Strong understanding of Quality Management Systems, risk-based quality management principles, and computerized system validation or validation lifecycle principles • Practical understanding of GDP, warehousing, logistics, and clinical trial supply processes is advantageous • Strong analytical, organizational, communication, stakeholder management, mentoring, and influencing skills, with the ability to manage multiple priorities, handle confidential information professionally, and apply a proactive, solutions-focused mindset

🏖️ Benefícios

• Medical, dental, and vision insurance • FSA, HSA • Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance • Group short-term and long-term disability insurance • Group Life Insurance • 401K safe harbor plan and company match • Paid vacation, holiday, sick and volunteer time • Paid maternity & paternity leave