Manager/Sr. Manager, Clinical GCP Quality Assurance

🕒 Abril 8

🏄 California – Remoto

🏄 California – Remote

💵 $150.000 - $170.000 / ano

⏰ Tempo Integral

🟠 Sênior

🔧 Engenheiro de QA (Qualidade de Software)

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Rakuten Medical

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2010

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

Biotechnology • Healthcare Insurance • Pharmaceuticals

A Rakuten Medical é uma empresa de biotecnologia dedicada a conquistar o câncer por meio de tratamentos inovadores. Utilizando a plataforma Alluminox™, que é baseada na fototerapia imunológica originalmente desenvolvida pelo Dr. Hisataka Kobayashi no National Cancer Institute, a Rakuten Medical foca na criação e comercialização de terapias avançadas contra o câncer. Sua missão é proporcionar acesso global a melhores tratamentos contra o câncer, independentemente da nacionalidade ou condição financeira do paciente, com ênfase no desenvolvimento de novos padrões de cuidados em oncologia.

Descrição

• Provide strategic and operational leadership in the planning and executing of GCP Quality activities to support companywide and clinical development/clinical trial Quality activities. • Successfully lead global and cross-functional quality projects • Maintains current knowledge of ever-changing clinical quality guidance and regulations. • Excellent communication and people skills to ensure cohesive and collaborative teamwork. • Demonstrated ability to implement and collaboratively drive company initiatives and policies. • Experience in clinical inspection readiness and acting as the point person for sponsor clinical inspections. Lead Quality hosting clinical site inspection by regulatory agencies highly preferred. • Direct experience to successfully manage and oversee CAPA plans (write, review, approve, close). • Successfully demonstrates ability to both conduct and manage sites, internal GCP and vendor audits as well as direct and guide audit follow-up actions. • Establish Quality and Cross-Functional SOPs, processes and associated documents. • Working closely with clinical pharmacovigilance team on supporting clinical trial safety. • Responsible for presenting & updating CGP quality metrics and reporting to Sr. Management. • Other duties as assigned.

🎯 Requisitos

• B.S. Degree in life sciences with advanced degree in a scientific discipline preferred. • Minimum of 10 years direct experience in GCP Quality Assurance and/or GCP Compliance. • Minimum of two years of GCP auditing (e.g. clinical site/clinical vendor) as lead auditor experience preferred. • Demonstrates strong problem-solving skills, written and verbal communication, and experience in critical QA review of clinical documents. • Previous experience with oncology, combination drug-device studies, and/or multi-regional with US based clinical trial experience is a plus. • Pharmacovigilance/Safety QA experience is a plus. • Medical Device GCP experience is a plus. • ISO Standard (e.g. ISO13485, ISO9001, ISO27001) understanding is a plus. • Medical Device Reporting (MDR) – FDA 21 CFR Part 803. • Pharmacovigilance laws -EU Regulation 520/2012 for drug safety monitoring. • Experiences with Clinical Quality Management on a risk-based approach is needed. • Electronic TMF, document, quality, and learning management systems experience • Strong organizational and project management skills. • Flexible thinking and team-oriented communication and coordination skills to be able to collaborate in a team environment. • Professional working proficiency in English.

🏖️ Benefícios

• flexible time off • stock options • 401k • medical • dental • vision plans • more for full time employees