Document Control Manager

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Cristcot

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2008

💊 Farmacêutico

🔬 Ciência

💰 $10.473.043 Venture Round - Cristcot em 2025-06

Pharmaceuticals • Science

Cristcot é uma empresa de desenvolvimento e pesquisa farmacêutica especializada em formulações de medicamentos inovadores e tecnologias de combinação de dispositivos medicamentosos discretas projetadas para melhorar a adesão do paciente, reduzir a carga do tratamento e integrar terapias no dia a dia. Fundada em 2008 e sediada em Austin, Texas, a Cristcot oferece design e execução de pesquisa clínica, engenharia de formulações e administração inovadoras, desenvolvimento de ensaios especializados e suporte à estratégia regulatória; sua principal terapia investigacional concluiu um estudo fundamental de Fase 3. A empresa foca em solucionar barreiras negligenciadas no gerenciamento de doenças, criando soluções intuitivas e econômicas que possibilitam um cuidado mais eficaz e confiante.

Descrição

• Manage the lifecycle of controlled documents including SOPs, work instructions, policies, and templates. • Administer and optimize the electronic document management system (eDMS) on an ongoing basis, as needed. • Ensure proper version control, archival, retrieval, and distribution of documents • Establish and maintain document control procedures aligned with GxP requirements • Ensure all documentation complies with FDA, EMA, ISO 13485, and ICH guidelines (e.g., 21 CFR Part 11, 210, 211, 820) • Support internal and external audits, inspections, and regulatory submissions • Maintain audit-ready documentation and ensure inspection readiness at all times • Partner with QA to enforce document control policies and best practices • Develop and implement scalable document control processes to support company growth • Identify gaps and drive continuous improvement initiatives • Lead implementation or upgrades of document management systems • Work closely with Quality, Regulatory, Clinical, CMC, Medical Device, Commercial, and Manufacturing teams • Train employees on document control procedures and systems • Serve as the subject matter expert (SME) for document control across the organization • Hire, mentor, and manage document control staff as the organization grows • Establish performance metrics and ensure high-quality output

🎯 Requisitos

• Bachelor’s degree in Life Sciences, Quality, or related field • 5–8+ years of experience in document control within biotech, pharma, or regulated industry • Strong knowledge of GxP requirements and regulatory standards (FDA, EMA, ISO 13485, Medical Device, and ICH) • Experience with electronic document management systems (e.g., Compliance Quest, Veeva Vault, MasterControl, Documentum) • Demonstrated ability to manage document lifecycles and ensure audit readiness • Experience in early-stage or rapidly scaling biotech companies preferred • Familiarity with clinical-stage and/or commercial manufacturing environments preferred • Experience supporting regulatory submissions (IND, NDA) preferred • Lean / Six Sigma or process improvement experience preferred • Exceptional attention to detail and organizational skills • Strong understanding of compliance and regulatory expectations • Ability to work independently in a fast-paced, evolving environment • Excellent communication and training skills • Problem-solving mindset with a focus on continuous improvement

🏖️ Benefícios

• Health insurance • Professional development opportunities