Manager, IT Assurance, Compliance

🕒 August 21

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

💻 IT Support

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ICU Medical

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🍽️ Food & Beverage

🏭 Manufacturing

Healthcare • Food & Beverage • Manufacturing

ICU Medical is a global leader in intravenous (IV) therapy, specializing in innovative medical products and technologies that enhance the safety and efficiency of IV therapy across various care settings. Founded in 1984 by clinicians, the company is dedicated to delivering clinically-relevant solutions, including infusion pumps, safety software, and vascular access devices. ICU Medical's commitment to improving patient care is reflected in their comprehensive portfolio that spans infusion therapy, airway management, hemodynamic monitoring, and temperature management, ensuring clinicians can meet the diverse challenges of patient care effectively.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

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