[Hiring] Manager, IT Assurance and Compliance @ICU Medical

Role Description

The Manager, IT Assurance and Compliance – Quality Systems is responsible for leading and managing the IT Quality Compliance program, ensuring alignment with corporate and site quality and compliance initiatives. This role oversees the establishment, maintenance, and continuous improvement of global IT assurance and compliance processes, including computer software assurance (CSA), software quality management (SQM), and regulatory compliance (GxP, SOX, and others). The manager provides strategic leadership, subject matter expertise, and operational support to proactively identify and address compliance risks, facilitate audits, and drive quality improvements across the organization. The role also supports continuous improvement through the appropriate use of automation, analytics, and emerging technologies to enhance quality, compliance, and operational efficiency.

Qualifications

• Expert knowledge of IT quality and regulatory disciplines (21 CFR, Annex 11, SOX, PCI, ISO 13485).
• Advanced understanding of computer software assurance (CSA), systems validation, and risk-based validation approaches (GAMP 5) and good documentation practices (GDocP).
• Experience in leading internal and external audit programs.
• Strong organization, time management, critical thinking skills, project management experience.
• Excellent written, verbal, presentation, and interpersonal communication skills.
• Proficient in software applications (Word, PowerPoint, Excel, Visio, eQMS, Smartsheet).
• Ability to write and implement global standard operating procedures.
• Team-oriented, cross-functional leadership with proven ability to train and influence without authority.
• Experience in lean processes to implement innovative solutions that enhance operational efficiency.
• Familiarity with data-driven reporting and continuous improvement methodologies.

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 (medical devices, life sciences, etc.).
• 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.

Benefits

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• Typically requires travel less than 10% of the time.

Company Description

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges. With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.