· Ensure execution of the full QMS Simplification and Harmonization Roadmap, from diagnostic and design through global implementation and sustainment.
· Plan and manage project scope, milestones, risks, governance, dependencies, and budget.
· Provide strategic advise to management to ensure Quality and compliance objectives are fully embedded throughout project phases.
· Secure conduction of current-state analyses including maturity assessments, process mapping, architecture reviews, and gap identification.
· Ensure that the future-state QMS is aligned with ISO standards, GxP principles, and regulatory expectations.
· Oversee transformation activities including process cleanup, hierarchy and workflow redesign, documentation reduction, and technology deployment.
· Coordinate cross-functional, cross-regional teams on global and local level to ensure timely and effective execution of all program activities.
· Lead change management efforts: stakeholder engagement, communications, training, and change readiness assessments.
· Support global site rollout to ensure solutions are consistent, scalable, and easy to implement.
· Define and monitor KPIs to measure impact (efficiency, documentation reduction, compliance outcomes, productivity).