Manager, IT Assurance, Compliance

🕒 Agosto 21

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

💻 Suporte de TI

👻 Score fantasma 11%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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ICU Medical

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

🏥 Saúde

🍽️ Alimentos e Bebidas

🏭 Manufatura

Healthcare • Food & Beverage • Manufacturing

A ICU Medical é líder global em terapia intravenosa (IV), especializada em produtos médicos e tecnologias inovadoras que melhoram a segurança e a eficiência da terapia IV em diversos ambientes de cuidado. Fundada em 1984 por clínicos, a empresa é dedicada a oferecer soluções clinicamente relevantes, incluindo bombas de infusão, software de segurança e dispositivos de acesso vascular. O compromisso da ICU Medical em aprimorar o cuidado ao paciente se reflete em seu portfólio abrangente que abrange terapia de infusão, manejo das vias aéreas, monitoramento hemodinâmico e gestão de temperatura, garantindo que os clínicos possam enfrentar eficazmente os diversos desafios do cuidado ao paciente.

Descrição

• Lead the enterprise IT Quality Systems Assurance and Compliance program, including internal and external audits • Interpret and apply government regulations and standards to the IT Quality Management System • Identify, escalate, and address IT compliance risks • Provide compliance training and guidance to IT and business teams globally • Create, revise, and maintain SOPs • Plan and support internal and external audits, regulatory inspections, and corrective actions • Maintain audit documentation and ensure timely closure of non-conformances • Improve audit readiness and monitoring through reporting and analytics tools • Ensure computer systems are validated and controlled according to regulatory requirements • Lead scalable IT assurance processes and manage lifecycle and test management tools • Maintain computerized systems in a validated state through change control, system inventory, and periodic review • Support automation solutions that improve quality system effectiveness • Identify process improvement, automation, analytics, and testing opportunities • Partner with IT and business stakeholders on quality and compliance solutions • Lead, mentor, and develop IT assurance and compliance team members • Drive large projects to completion • Support department leadership with compliance data • Provide subject matter expertise for IT supplier quality vendor audits • Collaborate with vendors and evaluate software tools and services • Facilitate training on test management tools and compliance best practices

🎯 Requisitos

• Must be at least 18 years of age • Bachelor’s degree in sciences, engineering, IT, or related technical field required; a combination of education and relevant experience may be considered in lieu of the required education • 10+ years of direct experience in IT quality assurance, compliance, and regulatory environments • Experience with FDA inspections, notified body audits, and global/multi-site quality systems • Experience managing team objectives, growth development, and weekly activities • Hands-on experience with software validation/testing in regulated environments • Experience managing/implementing lifecycle and test management tools • Experience working in Scrum/Agile environments and with systems integrations/data migration • Expert knowledge of IT quality and regulatory disciplines, including 21 CFR, Annex 11, SOX, PCI, and ISO 13485 • Advanced understanding of computer software assurance, systems validation, risk-based validation approaches (GAMP 5), and good documentation practices (GDocP) • Experience leading internal and external audit programs • Proficiency in Word, PowerPoint, Excel, Visio, eQMS, and Smartsheet • Ability to write and implement global standard operating procedures • Hands-on experience with test management tools, automation tools/scripts, APIs, and data conversion testing/automation is highly desired • Experience using automation, AI, or generative AI tools is highly desired • Familiarity with responsible AI practices is highly desired

🏖️ Benefícios

• Remote work arrangement • Travel typically less than 10% of the time