Executive Director, Quality Systems & Operational Excellence Lead

Key Responsibilities

• Owns QMS process design, harmonization, and the 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.
• Led 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.

Required Qualifications

• BS+ (Life Sciences, Engineering, Quality, or related)
• 18+ years Quality Systems / QMS (GxP) with audit support, lifecycle quality oversight from development through commercial operations, and measurable CI outcomes
• Demonstrated governance leadership and cross-functional influence, specifically through digitally focused initiatives
• Experience in pharmaceutical / biotech Quality Systems, global standards deployment, lifecycle management across Development QA to Commercial QA, and operating effectively within a virtual biotech environment (preferred)
• Proficient with Veeva Vault Quality / QMS, Quality Docs, and related quality system workflows including deviations, CAPA, change control, training, and document management