<p>Job Title: Staff IT QMS Systems Analyst - Transformation</p> <p>Department: Information Technology - Quality Management Systems (IT QMS)</p> <p>Manager/Supervisor: Senior Manager, Quality & Regulatory Systems - Information Technology</p> <p>FLSA Status: Exempt</p> <p>SOP Group: IT</p> <p>Company Overview:</p> <p>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.</p> <p>Position Overview:</p> <p>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.</p> <p>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.</p> <p>Key Responsibilities</p> <p>QMS Transformation & Strategic Delivery</p> <ul> <li> <p>Lead and execute QMS transformation initiatives, including system modernization, process redesign, digital enablement, and roadmap execution.</p> </li><li> <p>Partner closely with IT QMS leadership to translate strategy and future-state vision into actionable initiatives, solution designs, and delivery plans.</p> </li><li> <p>Identify opportunities to improve scalability, reduce technical debt, and enable long-term sustainability across the QMS landscape.</p> </li></ul> <p>Systems Analysis & Solution Design</p> <ul> <li> <p>Perform advanced business and systems analysis, partnering with stakeholders to define future-state requirements and solution approaches.</p> </li><li> <p>Design end-to-end system workflows, data flows, and process improvements aligned with global QMS standards and regulatory expectations.</p> </li><li> <p>Develop and maintain functional specifications, transformation artifacts, and system design documentation.</p> </li></ul> <p>Validation Governance & Compliance Oversight</p> <ul> <li> <p>Provide strategic governance and oversight for computer system validation (CSV) activities associated with QMS transformation initiatives.</p> </li><li> <p>Define and influence risk-based validation strategies, including validation scope, level of rigor, and approach, in alignment with regulatory expectations and internal procedures.</p> </li><li> <p>Serve as a validation subject matter expert for transformation initiatives, ensuring validation considerations are embedded early in solution design.</p> </li><li> <p>Partner with Quality and Regulatory stakeholders to ensure solutions remain inspection-ready, defensible, and compliant throughout their lifecycle.</p> </li><li> <p>Review and guide validation deliverables as appropriate for transformation initiatives, without serving as the primary execution or test authoring role.</p> </li></ul> <p>Technical Leadership & Platform Enablement</p> <ul> <li> <p>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.</p> </li><li> <p>Provide technical leadership and guidance across initiatives, influencing solution direction and architectural decisions.</p> </li><li> <p>Mentor and guide analysts and project team members to elevate overall QMS, validation, and delivery maturity.</p> </li></ul> <p>Integration, Automation & Innovation</p> <ul> <li> <p>Lead and support cross-system integration initiatives and data flow optimization to improve traceability and visibility.</p> </li><li> <p>Drive automation and AI-enabled improvements to reduce manual effort, enhance data quality, and improve compliance outcomes.</p> </li><li> <p>Evaluate emerging technologies and capabilities that align with QMS modernization and operational efficiency goals.</p> </li></ul> <p>Stakeholder, Vendor & Governance Collaboration</p> <ul> <li> <p>Serve as a trusted IT partner to Quality, Regulatory, R&D, Manufacturing, and other stakeholders throughout transformation initiatives.</p> </li><li> <p>Partner closely with the Senior Manager, Quality & Regulatory Systems - IT to align priorities, delivery approach, and validation governance.</p> </li><li> <p>Provide oversight and technical leadership for vendors and system integrators, ensuring alignment with Insulet's validation, compliance, and quality standards.</p> </li><li> <p>Represent IT QMS in governance forums related to system strategy, validation approach, and transformation roadmap planning.</p> </li></ul> <p>Operational Support (As Needed)</p> <ul> <li> <p>Provide limited, high-level support and guidance for existing QMS systems as needed, primarily in the context of transformation initiatives, critical issues, or cross-functional escalations.</p> </li><li> <p>Support activities are not expected to be day-to-day, ticket-driven, or operational, and remain secondary to transformation and governance responsibilities.</p> </li></ul> <p>Required Qualifications</p> <ul> <li> <p>Bachelor's degree in Information Systems, Computer Science, Engineering, or equivalent practical experience.</p> </li><li> <p>8+ years of experience in IT systems analysis, IT system validation, solution design, or application ownership within a regulated environment.</p> </li><li> <p>Strong experience supporting Quality Management Systems (QMS) or other regulated enterprise platforms.</p> </li><li> <p>Demonstrated experience working in GxP-regulated environments with validated systems.</p> </li><li> <p>Strong analytical, problem-solving, and documentation skills.</p> </li><li> <p>Ability to lead complex initiatives independently and influence without direct authority.</p> </li></ul> <p>Preferred Qualifications</p> <ul> <li> <p>Experience with QMS platforms such as Arena PLM, Veeva Vault (PromoMats, MedComms, RIMS), TrackWise, Polarion, or similar systems.</p> </li><li> <p>Experience with system modernization, digital transformation, or large-scale platform migrations.</p> </li><li> <p>Knowledge of system integrations, data flows, and enterprise architecture concepts.</p> </li><li> <p>Experience supporting AI, automation, or advanced analytics initiatives in regulated systems.</p> </li><li> <p>Strong understanding of computer system validation (CSV) best practices.</p> </li></ul> <p>NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office.</p> <p>Physical Requirements:</p> <ul> <li>Less than 10% Travel </li></ul> <p>Additional Information:</p> <p>Compensation & Benefits:</p> <p>For U.S.-based positions only, the annual base salary range for this role is $117,100.00 - $175,600.00</p> <p>This position may also be eligible for incentive compensation.</p> <p>We offer a comprehensive benefits package, including:</p> <ul> <li>Medical, dental, and vision insurance </li><li>401(k) with company match </li><li>Paid time off (PTO) </li><li>And additional employee wellness programs </li></ul> <p>Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online.</p> <p>Actual pay depends on skills, experience, and education.</p> <p>Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.</p> <p>We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!</p> <p>At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.</p> <p>(Know Your Rights)</p>