Manager, Global Quality Management System (QMS)

The Manager, Global QMS will lead and manage the global Quality Management Review (QMR) process, overseeing data collection, analysis, and reporting. This role is responsible for the global internal audit program, including planning, execution, reporting, and CAPA tracking. The manager will own the supplier qualification and management program, encompassing risk assessments, audits, and monitoring. They will drive global inspection readiness activities for health authority inspections and provide oversight and guidance to site QMR administrators for consistent quality system implementation. Key responsibilities include establishing and monitoring global QMS KPIs, trending quality metrics, and partnering with IT for QMS system enhancements, including defining requirements, prioritization, and validation. The role involves reviewing and approving validation documentation for global enterprise systems and collaborating with leadership teams to drive continuous improvement initiatives. The manager will also represent the Quality organization in interactions with external auditors, suppliers, and regulatory agencies as needed.