Senior Manager, Deviation Management – Quality Assurance

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 deviation management governance to ensure deviations are triaged, investigated, and closed in a timely, compliant, and high‑quality manner. Establishes standards for investigation rigor, root cause analysis, impact assessment, and linkage to CAPA and change control. Drives performance management (cycle time, backlog, aging) and trending to reduce recurrence and protect compliance and supply. Maintains inspection readiness through consistent documentation practices and governance routines across internal and external partners as applicable.

Coaches teams on investigation quality expectations and effective prevention actions.

• Process Ownership & Governance – Own deviation standards, templates, training expectations, and governance cadence (triage, backlog, aging, escalation). Ensure consistent severity classification and impact assessment expectations across teams / sites / partners. Produce deliverables such as deviation governance playbooks, triage guides, and KPI dashboards.
• Investigation Quality & CAPA Linkage – Drive RCA rigor and evidence standards, coach investigators and ensure high‑quality conclusions and documentation. Ensure CAPA linkage, effectiveness checks, and recurrence prevention are implemented and verified. Produce deliverables such as investigation quality checklists, CAPA linkage reports, and effectiveness review summaries.
• Trending & Inspection Readiness – Own deviation trending and management review inputs, identify systemic themes and drive cross‑functional actions. Maintain inspection‑ready deviation records and process narratives, support audits / inspections and responses. Produce deliverables such as trend reports, management review packs, and inspection‑ready narratives.

• BS+ in Science / Engineering (or related)
• 7–10 years in GMP QA / QMS with strong deviation / investigation leadership experience
• Demonstrated improvements in cycle time, investigation quality, and recurrence reduction

• Experience in pharmaceutical / biotech external manufacturing networks and partner deviation governance (preferred)
• Experience with eQMS workflows and continuous improvement / problem‑solving facilitation

• Deviation governance, investigation quality standards, and cycle‑time / backlog management, escalation, and action closure discipline
• RCA facilitation, CAPA linkage, and effectiveness verification, recurrence prevention, and trending insights
• Partner governance and performance management across sites / CMOs for deviation quality and responsiveness (as applicable)
• Cross‑functional leadership,…