Digital Quality Manager – GxP

Vaga não está no LinkedIn

🕒 Outubro 14

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $110.000 - $140.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

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CARE

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

Fundada em 1945

🍽️ Alimentos e Bebidas

🏥 Saúde

📦 Logística

💰 Grant em 2021-11

Food & Beverage • Healthcare • Logistics

A CARE é uma organização humanitária global dedicada a acabar com a pobreza e oferecer ajuda vital. Há quase 80 anos, a organização fornece resposta a emergências, alimentos e água, serviços de saúde, educação e programas voltados para mulheres e meninas em mais de 120 países, enfatizando soluções lideradas localmente e alta eficiência dos programas. A CARE opera como uma organização sem fins lucrativos 501(c)(3) que arrecada doações e mobiliza esforços de advocacia e desenvolvimento para aliviar a fome, promover a igualdade e apoiar a resiliência comunitária a longo prazo.

Descrição

• Review and approve validation of software and AI products to ensure full compliance with regulatory requirements and company policies • Prepare for and support external regulatory audits • Lead internal or vendor audits related to maintaining GxP and regulatory compliance • Develop and maintain digital/software components of quality management systems, including AI quality management systems • Proactively monitor systems and processes for compliance with standard operating procedures, audit compliance, and industry best practices • Review key vendors for compliance with digital quality requirements • Train and educate internal stakeholders on quality processes and best practices • Perform other tasks and special projects assigned by quality leadership • Build and maintain collaborative relationships with internal and external stakeholders across departments • Travel up to 40% as required

🎯 Requisitos

• Demonstrated leadership experience in implementing compliance programs within the software industry • Experience with Good Clinical Practice is required • Demonstrated experience with SaaS application and agile product development methodology • Excellent communication and interpersonal skills • Strong analytical skills with the ability to effectively define business issues and recommendations • High attention to detail and organizational skills • Technical proficiency and understanding of data management in healthcare or clinical trial spaces • Highly detail-oriented with strong time management skills to manage multiple deadlines • Ability to work with minimal supervision and manage multiple priorities in a fast-paced environment • 3+ years of experience implementing GxP standards and advising on matters of quality compliance at a SaaS company, including GxP systems validation • Certifications in GxP quality, computer systems validation processes or quality systems management preferred • Must be able to work remotely within the United States • Care Access is unable to sponsor work visas at this time

🏖️ Benefícios

• Paid Time Off (PTO) and Company Paid Holidays • 100% Employer paid medical, dental, and vision insurance plan options • Health Savings Account and Flexible Spending Accounts • Bi-weekly HSA employer contribution • Company paid Short-Term Disability and Long-Term Disability • 401(k) Retirement Plan, with Company Match

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