About this opportunity
Madrigal Pharmaceuticals, Inc. lists this Director, Quality – New Product Development Lead opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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. 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.
Key Responsibilities
Portfolio Leadership & Operating Model Define development quality operating model, governance forums, and performance metrics, ensure consistent decision quality across programs
Prioritize portfolio support and escalat(e) resource, timeline, and quality risks with mitigation options
Produce deliverables such as portfolio dashboards, governance calendars, and resourcing / risk briefs
Development Oversight & Partner Governance 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
Inspection Readiness & Continuous Improvement 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
Required Qualifications
BS+ Life Sciences / Engineering (or related) 12-15 years QA experience with significant development portfolio leadership experience
Demonstrated people leadership and executive stakeholder influence
Preferred Qualifications
Experience in pharmaceutical / biotech across multiple modalities and external development networks (preferred)
Experience supporting inspections and major submissions / filings readiness
Key Competencies
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
Compensation
Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $211,591 - $240,461 per year. We comply with all applicable minimum wage laws.
All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
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
other offerings
mental health benefits through our Employee Assistance Program for employees and their family
other benefits in accordance with applicable federal, state, and local laws
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment 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.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment 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.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.