Associate Director, Development Quality - OSD

Provides modality-focused development QA leadership for oral programs, ensuring phase-appropriate oversight, risk management, and compliant execution across internal teams and external partners. Owns program-level quality strategy, governance cadence, and readiness milestones and ensures development documentation is traceable and inspection-ready. Partners with CMC and clinical supply stakeholders on control strategy evolution, tech transfer readiness, and issue management. Supports efficient progression toward commercialization while maintaining compliance and predictable execution. Key Responsibilities Program QA Leadership (Oral) • Own quality strategy, governance cadence, and risk register for assigned oral programs, define and track readiness milestones • Guide application of QMS processes (deviations / CAPA / change control) in development context and ensure timely closure • Produce deliverables such as program quality plans, readiness trackers, and decision / action logs Partner Oversight & Inspection Readiness • Oversee external vendors / CMOs supporting oral development activities as applicable, ensure governance and escalation pathways • Maintain inspection-ready documentation, narratives, and evidence packages for program scope • Produce deliverables such as vendor governance packs, audit readiness checklists, and inspection evidence indexes Required Qualifications • BS+ Life Sciences / Engineering (or related) • 10-12 years QA experience with development-stage oversight • Demonstrated cross-functional leadership and risk-based judgment Preferred Qualifications • Experience in pharmaceutical / biotech oral product development and clinical supply interfaces (preferred) • Experience with external development networks and inspection support Key Competencies • Development QA governance, phase-appropriate oversight, and readiness milestone management for oral programs • Change management (impact assessment, stakeholder mapping, communications, training / SOP readiness, adoption measurement) • Partner governance and performance management across CMOs / vendors, inspection readiness evidence discipline • Cross-functional leadership, escalation, and executive-ready risk / decision communication • Quality risk management, issue triage, and timely action closure across development stakeholders • Veeva Vault Quality (eQMS) proficiency to track program quality events, vendor oversight, and readiness documentation 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 $168,737 - $198,073 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.