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Solution Architect – Quality, QMS

🕒 Outubro 2

🍂 Massachusetts – Remoto

infoinfo

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

💻 Engenheiro de Soluções

🗣️🇺🇸🇬🇧 Inglês obrigatório

Vault

De onde vem esta vaga

Publicada na página de carreiras da Kivo, não em um site de vagas

Vista pela primeira vez pelo Remote Rocketship Outubro 2

Ainda aberta no site da Kivo. Verificada 11 minutos atrás.

Logo of Kivo

Kivo

11 - 50 funcionários

Fundada em 2021

🏥 Saúde

💼 Consultoria

⚕️ Seguro de Saúde

💰 $3.000.000 Seed Round em 2022-04

Healthcare • Consulting • Healthcare Insurance

A Kivo é uma plataforma de gestão de documentos, conteúdo e processos, compliance, especificamente adaptada para a indústria de ciências da vida. Oferece soluções para Gestão de Documentos (DMS), Arquivo Mestre de Ensaios Eletrônicos (eTMF), Gestão de Informações Regulatórias (RIM) e Gestão da Qualidade (QMS). Projetada para empresas farmacêuticas e de dispositivos médicos, a Kivo ajuda a otimizar fluxos de trabalho, garantir compliance e gerenciar a documentação ao longo de seu ciclo de vida, tudo enquanto oferece acessibilidade e operações fáceis de usar.

Descrição

• Engage early in the sales process to assist with requirements definition and project scoping • Lead end-to-end implementations of the Kivo platform through structured project management and governance • Facilitate discovery and design workshops • Translate regulated process requirements into configured platform solutions with documented decisions • Guide customer adoption of Kivo • Educate customers on Kivo’s validation methodology and orient them to Kivo documentation • Partner with the Data Migration team on discovery, field mapping, dry-run coordination, and production cutover checklists • Guide change management activities including defect triage, go-live readiness assessments, user training enablement, and post-go-live stabilization • Manage a portfolio of North American accounts as the primary strategic post-implementation contact • Build and maintain tailored success plans aligned with customer business goals • Partner with Sales to identify, qualify, and advance expansion and upsell opportunities • Cultivate senior-level customer relationships and deliver executive-ready insights, business reviews, and ROI narratives • Surface customer feedback, advocate for roadmap priorities, and collaborate with Product on features and packaged offerings • Manage customer adoption of new feature releases and configuration changes • Own GRR and NRR metrics; execute playbooks for at-risk accounts, renewals, and expansion conversations

🎯 Requisitos

• 5–10+ years of experience in a customer success, implementation, or blended services role within a life-sciences SaaS environment (pharma, biotech, med-device, or CRO) • Strong domain knowledge of Quality process in the pharmaceutical/biotech or medtech industries • Demonstrated track record managing across a portfolio of accounts • Working knowledge of regulated industry requirements (GxP, 21 CFR Part 11 / Annex 11) • Comfort supporting validation deliverables (CSA/CSV) • Experience leading software implementations in a regulated environment, including project planning, stakeholder management, and go-live delivery • Excellent written and verbal communication skills in English • Comfortable presenting to technical users and C-suite stakeholders • Based in the US with flexibility to occasionally time-shift for EU-based project collaboration • Applied AI experience with AI models such as Claude, ChatGPT, or Copilot to build workflows, automations, or skills, and ability to guide customers in their use • Hands-on experience with life-sciences SaaS platforms such as Vault, MasterControl, TrackWise/ETQ, or comparable eQMS, eTMF, or RIM systems • Prior experience working in hyper-growth, fast-paced environments and managing multiple priorities • Bachelor’s degree in computer science or equivalent experience

🏖️ Benefícios

• Balance outside the office • PMP, Agile/Scrum certification, or equivalent project management training mentioned as a nice-to-have development qualification

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Desenvolvido por Lior Neu-ner. Adoraria receber seu feedback — entre em contato por DM ou pelo e-mail support@remoterocketship.com
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