Executive Director, Quality Systems & Operational Excellence Lead

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction‑associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.

Madrigal’s medication, Rezdiffra (resmetirom), is a once‑daily, oral, liver‑directed THR‑β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).

Our success is driven by our people. We are building a dynamic, inclusive, and high‑performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

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, 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.

• Own QMS architecture, process ownership model, and standards / templates, drive harmonization across teams / partners as applicable, including Development QA, IT QA, and Commercial QA interfaces across the product lifecycle
• Maintain SOP governance, periodic reviews, training impact requirements, document control, and training compliance across a virtual biotech organization, ensuring fit‑for‑purpose processes and inspection‑ready records
• Produce deliverables such as QMS process maps, SOP governance calendars, standards / template libraries, lifecycle quality event trending reports, and training / document control dashboards

• Lead OPEX portfolio (simplification, RFT, cycle time reduction) with benefits tracking and sustainment controls
• Own Quality KPI framework and cadence, Lead Quality Management Review coordination, Change Control Committees, quality event trending reviews, and support management review materials and action tracking
• Produce deliverables such as OPEX roadmap, benefits tracker, KPI pack, and management review decks

• Ensure QMS documentation and evidence are audit / inspection‑ready, drive remediation plans for gaps
• Maintain process narratives and consistency of execution across the organization
• Produce deliverables such as inspection readiness checklists, evidence indexes, and remediation trackers

• 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,…