Job 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.

Essential Duties & Responsibilities

Compliance Leadership

• 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 (QMS).
• Identify, escalate, and address IT compliance risks throughout the organization.
• Provide compliance training and guidance to IT and business teams globally.
• Create, revise and maintain SOPs to adapt to regulatory requirements and industry best practices.

Audit Management

• Ensure appropriate support for internal and external audit programs, including audit planning, execution, and corrective action development.
• Drive rapid response and support regulatory inspections (FDA, ISO 13485, MDSAP, and other applicable regulations).
• Maintain audit documentation, ensuring timely closure of non-conformances.
• Leverage approved reporting and analytics tools to improve audit readiness and monitoring activities.

IT Quality Systems Oversight

• Ensure company computer systems are validated and controlled to comply with regulatory requirements (21 CFR Part 11, Annex 11, and other regional QMS regulations).
• Lead the deployment of scalable IT assurance processes, leveraging regulatory commonalities to eliminate redundant efforts.
• Manage lifecycle and test management tools to support effective software quality management and computer software assurance (CSA).
• Maintain computerized systems in a validated state through change control, system inventory, and periodic review.
• Support implementation of automation solutions that improve quality system effectiveness.

Continuous Improvement & Automation

• Identify opportunities to improve efficiency, quality, and compliance through process improvement, automation, analytics, and testing tools.
• Partner with IT and business stakeholders to evaluate solutions that support quality and compliance objectives.
• Ensure automation solutions are appropriately documented and implemented in accordance with company procedures and regulatory requirements.

Team & Project Management

• Lead, mentor, and develop IT assurance and compliance team members.
• Drive large projects to completion, ensuring alignment with organizational goals.
• Support department leadership in preparing and presenting compliance data.

Vendor & Supplier Quality

• Provide SME support for IT supplier quality vendor audits, including software and services (IaaS, PaaS).
• Collaborate with vendors to ensure compliance with internal and external requirements.
• Evaluate software tools and services that support quality, compliance, and testing activities.

Training & Communication

• Facilitate training on test management tools, and compliance best practices.
• Support training related to approved quality and process improvement tools.
• Communicate effectively with stakeholders at all levels, providing clear guidance and support.

Knowledge & Skills

• 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.

Highly Desired

• Hands-on experience with test management tools, automation tools/scripts, APIs, data conversion testing/automation.
• Experience using automation, AI, or generative AI tools to improve testing, traceability, evidence review, defect management, quality metrics, reporting, documentation, analytics, or process improvement.
• Familiarity with responsible AI practices, including human review, data protection, risk awareness, output verification, and documentation of AI-assisted work in controlled business environments.

Minimum Qualifications, Education & Experience

• 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.

Work Environment

• 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

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.

We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

• 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.

This role is based remotely; the incumbent may be remote in any state other than Colorado; California; Connecticut; Montana, Maine or New York.

ICU Medical EEO Statement:

ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.