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