Owns QA disposition and release of clinical supplies to support trial timelines while ensuring compliant, traceable execution. Ensures batch / packaging record completeness, labelling readiness, and release criteria execution for investigational products and clinical supply operations. Coordinates closely with Clinical Ops, CMC, Supply Chain, and external vendors to manage priorities and reduce release bottlenecks. Oversees deviations, investigations, and change controls impacting clinical release timelines with risk-based assessment and documentation rigor. Maintains inspection readiness through audit-ready clinical supply release documentation and governance. Key Responsibilities Disposition / Release Execution • Own release criteria, checklists, and documentation standards, ensure consistent, compliant disposition decisions • Drive cycle-time and right-first-time improvements for clinical release workflows • Produce deliverables such as release checklists, release dashboards, and clinical release cycle-time reports • Ensure QA oversight over clinical packaging runs Issue Management & Cross-Functional Coordination • Coordinate deviations / investigations / change controls impacting release timelines, ensure timely risk assessments and action closure • Partner with Clinical Ops / Supply Chain on release schedules, priorities, and mitigation plans • Produce deliverables such as release risk summaries, issue / action logs, and escalation briefs Inspection Readiness & Vendor Oversight (as applicable) • Maintain audit-ready release documentation and evidence packages, support GxP inspections • Oversee external clinical vendors as applicable and ensure compliance with labelling / packaging expectations • Produce deliverables such as inspection-ready evidence indexes and vendor oversight packs Required Qualifications • BS+ Science / Engineering (or related) • 15+ years GMP QA / release experience (clinical supply experience strongly relevant) • Strong documentation discipline and cross-functional coordination capability • Ability to travel 20-30%, both domestic and international Preferred Qualifications • Experience in pharmaceutical / biotech clinical supply chains, IMP labelling / packaging, and external clinical vendors (preferred) • Experience supporting GxP inspections involving clinical supply release activities Key Competencies • Clinical supply release governance, batch / packaging record review, and disposition decision-making, cycle-time management • Labelling / packaging readiness interface and controlled documentation discipline, inspection readiness evidence quality • Deviation / investigation / change control coordination for clinical timelines, risk-based escalation, and action closure • Partner governance and performance management across external clinical vendors (as applicable) • Cross-functional leadership, escalation, and executive-ready risk / decision communication • Veeva Vault Quality (eQMS) proficiency to manage clinical release documentation and quality events impacting timelines 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 $244,600 - $299,000 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.