• Lead the design, implementation, and continuous improvement of a unified, enterprise-wide QMS across global sites and business units. • Drive QMS standardization, simplification, and integration following mergers, acquisitions, and organizational changes. • Ensure QMS documentation, procedures, records, and workflows meet global regulatory requirements and reflect industry best practices. • Develop and oversee the annual internal audit program, including risk-based audit planning, auditor qualification, and audit execution. • Lead preparation, readiness, and hosting of external audits/inspections, including FDA, ISO Notified Bodies, MDSAP, and customer audits. • Establish, track, and report enterprise-level quality metrics and KPIs through standardized dashboards and scorecards. • Develop and mentor a high-performing Quality Systems & Compliance team. • Champion a culture of quality and compliance throughout the organization.