Executive Director, Quality Systems & Operational Excellence Lead

Position Summary

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. 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, supporting lifecycle management, continuous improvement, and risk‑based decision making within a virtual biotech operating model.

• Design, standards, and governance of QMS architecture, process ownership model, and harmonization across teams and partners.
• Maintain SOP governance, periodic reviews, training impact requirements, document control, and training compliance across a virtual biotech organization.
• Produce deliverables such as QMS process maps, SOP governance calendars, standards and template libraries, lifecycle quality event trending reports, and training/document control dashboards.
• Lead OPEX portfolio with simplification, RFT, and cycle‑time reduction, tracking benefits and sustainment controls.
• Own Quality KPI framework, cadence, and lead management review coordination, change control committees, and quality event trending reviews.
• Ensure QMS documentation and evidence are audit/inspection‑ready, drive remediation plans, and maintain process narratives and consistency.

• BS+ in Life Sciences, Engineering, Quality, or related field.
• 18+ years of quality systems/GxP experience with audit support and lifecycle quality oversight from development through commercial operations.
• Governance leadership and cross‑functional influence, particularly through digitally focused initiatives.

• Experience in pharmaceutical/biotech quality systems, global standard deployment, and lifecycle management across Development QA to Commercial QA.
• Experience operating within a virtual biotech environment.
• Proficiency with Veeva Vault Quality/QMS and related quality system workflows (deviations, CAPA, change control, training, and document management).

• QMS architecture, process harmonization, and governance.
• SOP lifecycle management, quality event trending, document control, and training oversight.
• Operational excellence leadership, KPI cadence facilitation, benefits tracking, and cycle‑time improvement.
• Deep knowledge of quality technology architecture and leading quality solutions.
• Strategic and implementation expertise in AI use cases in quality.
• Data management best practices to drive a consistent and connected quality data foundation.
• Change management, stakeholder mapping, communications, training readiness, and adoption measurement.
• Cross‑functional leadership, escalation, and executive‑ready risk/decision communication.
• Inspection readiness discipline, audit narrative readiness, evidence retrieval, traceability, and virtual biotech organization operation.

Competitive total rewards strategy: base salary $276,000–$337,000 per year, bonus, equity, and a comprehensive benefits suite. Benefits include flexible paid time off, medical, dental, vision, life/disability insurance, 401(k) with employer match, supplemental life insurance, legal services, mental health support, and additional voluntary benefits. Equity opportunities reinforce ownership culture.

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need, and consideration is given without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.