Staff Information Technology Analyst

Job Title:                                          Staff IT QMS Systems Analyst – Transformation

Department:                                   Information Technology – Quality Management Systems (IT QMS)

Manager/Supervisor:                  Senior Manager, Quality & Regulatory Systems – Information Technology

FLSA Status:                                    Exempt

SOP Group:                                     IT

Company Overview:

Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives using our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe. We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it.

Position Overview:
The Staff IT QMS Systems Analyst – Transformation is a senior individual contributor responsible for driving the modernization, transformation, and future‑state evolution of Insulet’s Quality Management Systems (QMS). This role focuses on strategic initiatives including platform modernization, process digitization, system integration, automation, and adoption of new capabilities across the QMS ecosystem.

This role is a key member of the IT QMS team and partners closely with the Senior Manager, Quality & Regulatory Systems – IT to lead QMS transformation initiatives and provide validation governance oversight. The position is a strategic transformation and governance partner, working collaboratively to deliver scalable, compliant, and inspection‑ready solutions.

Key Responsibilities

QMS Transformation & Strategic Delivery

• Lead and execute QMS transformation initiatives, including system modernization, process redesign, digital enablement, and roadmap execution.

• Partner closely with IT QMS leadership to translate strategy and future‑state vision into actionable initiatives, solution designs, and delivery plans.

• Identify opportunities to improve scalability, reduce technical debt, and enable long‑term sustainability across the QMS landscape.

Systems Analysis & Solution Design

• Perform advanced business and systems analysis, partnering with stakeholders to define future‑state requirements and solution approaches.

• Design end‑to‑end system workflows, data flows, and process improvements aligned with global QMS standards and regulatory expectations.

• Develop and maintain functional specifications, transformation artifacts, and system design documentation.

Validation Governance & Compliance Oversight

• Provide strategic governance and oversight for computer system validation (CSV) activities associated with QMS transformation initiatives.

• Define and influence risk‑based validation strategies, including validation scope, level of rigor, and approach, in alignment with regulatory expectations and internal procedures.

• Serve as a validation subject matter expert for transformation initiatives, ensuring validation considerations are embedded early in solution design.

• Partner with Quality and Regulatory stakeholders to ensure solutions remain inspection‑ready, defensible, and compliant throughout their lifecycle.

• Review and guide validation deliverables as appropriate for transformation initiatives, without serving as the primary execution or test authoring role.

Technical Leadership & Platform Enablement

• Act as a senior technical subject matter expert for QMS platforms and capabilities, with a focus on transformation and optimization rather than day‑to‑day administration.

• Provide technical leadership and guidance across initiatives, influencing solution direction and architectural decisions.

• Mentor and guide analysts and project team members to elevate overall QMS, validation, and delivery maturity.

Integration, Automation & Innovation

• Lead and support cross‑system integration initiatives and data flow optimization to improve traceab