Executive Director, Quality Systems & Operational Excellence Lead

Owns QMS process design, harmonization, and operational excellence roadmap to ensure consistent, efficient, inspection-ready execution. Establishes standards, templates, and governance for core QMS processes and drives simplification and cycle-time reduction initiatives. Owns the Quality KPI framework and management review support materials, ensuring metrics are reliable and drive action. Leads adoption of best practices across the Quality organization and ensures QMS documentation remains current, controlled, and effective. Maintains readiness for audits and inspections through strong governance discipline and evidence control. Leads quality event trending and signal detection across the product lifecycle, ensuring meaningful insight generation and management review from Development QA through Commercial QA in support of lifecycle management, continuous improvement, and risk-based decision making within a virtual biotech operating model.