Staff Information Technology Analyst

Insulet Corporation•Acton, MA

1d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in Information Systems, Computer Science, Engineering, or equivalent practical experience.
8+ years of experience in IT systems analysis, IT system validation, solution design, or application ownership within a regulated environment.
Strong experience supporting Quality Management Systems (QMS) or other regulated enterprise platforms.
Demonstrated experience working in GxP‑regulated environments with validated systems.
Strong analytical, problem‑solving, and documentation skills.
Ability to lead complex initiatives independently and influence without direct authority.

Nice To Haves

Experience with QMS platforms such as Arena PLM, Veeva Vault (PromoMats, MedComms, RIMS), TrackWise, Polarion, or similar systems.
Experience with system modernization, digital transformation, or large‑scale platform migrations.
Knowledge of system integrations, data flows, and enterprise architecture concepts.
Experience supporting AI, automation, or advanced analytics initiatives in regulated systems.
Strong understanding of computer system validation (CSV) best practices.

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 traceability and visibility.
Drive automation and AI‑enabled improvements to reduce manual effort, enhance data quality, and improve compliance outcomes.
Evaluate emerging technologies and capabilities that align with QMS modernization and operational efficiency goals.
Stakeholder, Vendor & Governance Collaboration Serve as a trusted IT partner to Quality, Regulatory, R&D, Manufacturing, and other stakeholders throughout transformation initiatives.
Partner closely with the Senior Manager, Quality & Regulatory Systems – IT to align priorities, delivery approach, and validation governance.
Provide oversight and technical leadership for vendors and system integrators, ensuring alignment with Insulet’s validation, compliance, and quality standards.
Represent IT QMS in governance forums related to system strategy, validation approach, and transformation roadmap planning.
Operational Support (As Needed) 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.
Support activities are not expected to be day‑to‑day, ticket‑driven, or operational, and remain secondary to transformation and governance responsibilities.