Director, Quality – New Product Development Lead
About The Position
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.
Requirements
- BS+ Life Sciences / Engineering (or related)
- 12–15 years QA experience with significant development portfolio leadership experience
- Demonstrated people leadership and executive stakeholder influence
- Portfolio leadership, operating model design, and governance discipline, prioritization, resourcing, and performance cadence ownership
- Cross-functional leadership, escalation, and executive-ready risk / decision communication
- Partner governance and performance management across external development networks, audit / inspection readiness planning
- Quality risk management, phase-appropriate QMS application, and readiness milestone governance across programs
- Change management (stakeholder mapping, communications, training / standardization readiness, adoption measurement) and continuous improvement sponsorship
- Veeva Vault Quality (eQMS) proficiency to enable portfolio governance visibility and inspection-ready documentation control
Nice To Haves
- Experience in pharmaceutical / biotech across multiple modalities and external development networks (preferred)
- Experience supporting inspections and major submissions / filings readiness
Responsibilities
- Leads development quality strategy and execution across the new product development portfolio, ensuring phase-appropriate controls and consistent governance across programs and modalities.
- Establishes operating model expectations, standards, and performance cadences for development QA delivery.
- Partners with CMC and clinical supply leaders to embed quality risk management early, align readiness milestones, and enable efficient progression toward commercialization.
- Sets partner / vendor oversight standards and ensures inspection readiness through controlled documentation and audit-ready narratives.
- Sponsors continuous improvement to increase predictability, throughput, and right-first-time documentation.
- Define development quality operating model, governance forums, and performance metrics, ensure consistent decision quality across programs.
- Prioritize portfolio support and escalate resource, timeline, and quality risks with mitigation options.
- Produce deliverables such as portfolio dashboards, governance calendars, and resourcing / risk briefs.
- Ensure phase-appropriate QMS application and documentation traceability across programs and external partners.
- Set expectations for vendor oversight, audits, issue management, and readiness deliverables.
- Produce deliverables such as vendor oversight standards, audit strategies, and readiness playbooks.
- Maintain readiness for development inspections and submission support, ensure narratives and evidence are current and retrievable.
- Sponsor CI initiatives to improve cycle time, RFT documentation, and predictable execution across the portfolio.
- Produce deliverables such as inspection readiness plans, evidence indexes, and CI roadmaps / benefits trackers.
Benefits
- flexible paid time off
- medical
- dental
- vision
- life/disability insurance
- 401(k) offerings (i.e., traditional, Roth, and employer match)
- supplemental life insurance
- legal services
- mental health benefits through our Employee Assistance Program
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What This Job Offers
Job Type
Full-time
Career Level
Director
