Director, Quality - New Product Development Lead

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 escalate 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 Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing 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. All employees receive equity, which we believe reinforces our ownership culture. 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. Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.