Executive Director, Development Quality Lead

About Madrigal Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction‑associated steatohepatitis (MASH). The company’s lead medication is Rezdiffra, the first and only FDA and European Commission approved therapy for moderate to advanced fibrosis (F2‑F3) and is currently being evaluated in a Phase3 study for compensated MASH cirrhosis (F4c). Position Overview Provide phase‑appropriate Quality Assurance leadership for development activities, embedding quality planning and risk management into development execution, and establishing governance for development quality oversight. Key Responsibilities Define phase‑appropriate QA oversight model and governance cadence, ensuring readiness milestones and deliverables are clear. Embed risk management into development execution, ensuring documentation expectations and traceability are met. Produce deliverables such as program quality plans, risk registers, and readiness milestone trackers. Guide deviations, CAPA, and change control expectations for development activities, ensuring timely risk‑based decisions and closures. Support tech transfer and scale‑up readiness planning with CMC and clinical supply stakeholders. Produce governance packs, decision logs, and readiness checklists. Oversee development partners/vendors, driving issue resolution and oversight governance. Maintain inspection readiness plans, evidence packages, and training/standards for development quality. Produce vendor oversight plans, audit schedules, and inspection‑ready evidence indexes. Required Qualifications BS+ in Life Science, Engineering, or related discipline. 18+years experience in QA (development or tech ops preferred), with governance and audit support experience. Demonstrated cross‑functional leadership and risk‑based judgment. Preferred Qualifications Experience in pharmaceutical or biotech development quality and supporting development inspections/submission readiness. Experience overseeing CRO/CMO development partners. Key Competencies Development QA governance, phase‑appropriate oversight, and readiness milestone management. Quality risk management and decision support, deviation/CAPA/change control application in development context. Partner/vendor oversight and audit readiness planning, issue escalation and follow‑through across external networks. Cross‑functional leadership, escalation, and executive‑ready risk/decision communication. Control strategy evolution partnering with CMC and clinical supply, tech transfer/scale‑up readiness alignment. Veeva Vault Quality (eQMS) proficiency to manage development QMS records and inspection‑ready traceability. Benefits & Compensation Base salary estimate: $276,800 – $338,300 per year, determined by qualifications, experience, and market demand. All full‑time employees receive equity and are eligible for a comprehensive benefits package that includes flexible paid time off, medical, dental, vision, life and disability insurance, and 401(k) offerings (traditional, Roth, and employer match). Additional voluntary benefits include supplemental life insurance, legal services, and mental health support through an Employee Assistance Program. Equal Opportunity Employer Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration 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 law. #J-18808-Ljbffr