Serve as a strategic thought partner and Chief of Staff to the SVP, CQRCO
Translate Quality, Regulatory, and Compliance vision into clear enterprise strategy and execution roadmaps
Establish governance, operating cadence, and program management discipline across Quality & Regulatory initiatives
Drive cross-functional alignment and execution of high‑priority, enterprise‑critical programs
Enable executive decision-making through insightful analysis, scenario planning, and performance tracking
Support organizational readiness for regulatory inspections, audits, and major external milestones
Strengthen integration and coordination across Quality, Regulatory, Compliance, R&D, Manufacturing, Supply Chain, and Commercial teams

Bachelor’s degree required; advanced degree (MBA, MS, PhD, JD) strongly preferred
12+ years of progressive experience in Quality, Regulatory Affairs, Compliance, Strategy, PMO, or Management Consulting
Demonstrated experience supporting or partnering with C‑suite or senior executive leaders in a Chief of Staff, strategy, or enterprise PMO capacity
Deep understanding of FDA regulations, global regulatory frameworks, quality systems, and inspection readiness
Proven track record leading complex, cross‑functional enterprise programs with material business impact
Strong analytical capabilities, with the ability to synthesize complex data into clear executive insights
Exceptional communication skills (written, verbal, executive presence).

Senior Director, Quality and Regulatory Strategy and Operations

Key skills