Director, Quality – New Product Development Lead

Madrigal; Conshohocken (Montgomery County); Vor Ort; USD 212.000 - 240.000; Vollzeit

Benefits dieser Stelle

Flexible PTO

Medical

Dental

Vision

Life/disability insurance

401(k) options

Supplemental life

Legal services

Employee assistance program

Zusammenfassung

Madrigal is expanding its development quality team and seeks an experienced leader to steer quality strategy across the portfolio. You will oversee governance, risk, and readiness activities with external partners, ensuring inspection-readiness and compliant documentation.

Qualified candidates bring a strong QA leadership track record, cross-functional collaboration skills, and expertise in QMS systems, especially Veeva Vault Quality, to enable efficient program progression and high-quality

Qualifikationen

• BS+ Life Sciences / Engineering (or related) 12-15 years QA experience with significant development portfolio leadership experience
• Demonstrated people leadership and executive stakeholder influence

Aufgaben

• Portfolio Leadership & Operating Model: Define development quality operating model, governance forums, and performance metrics.
• 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.
• Inspection Readiness & Continuous Improvement: Maintain readiness for development inspections and submission support, ensure narratives and evidence are current and retrievable.

Kenntnisse

QA leadership

Executive stakeholder influence

Cross-functional leadership

Veeva Vault Quality

Ausbildung

BS Life Sciences / Engineering

Tools

Veeva Vault Quality (eQMS)

Jobbeschreibung

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.