Director, Quality – New Product Development Lead

Role: Lead development quality strategy and execution across Madrigal's biopharmaceutical pipeline, ensuring phase-appropriate controls, governance, and readiness for regulatory inspections. Responsibilities: establish operating models, oversee vendor and partner governance, manage inspection readiness, and drive continuous improvement initiatives within the development portfolio. Collaborate closely with CMC and clinical supply teams to embed quality risk management and ensure documentation readiness for filings. Requirements: BS+ in Life Sciences or Engineering; 12–15 years of QA experience with significant leadership in development portfolios; proven ability to influence senior stakeholders. Preferred: experience in pharmaceutical/biotech across multiple modalities, supporting inspections, and regulatory submissions. HighValue: focus on metabolic disease therapeutics, with emphasis on development quality management during preclinical, IND, and clinical stages; expertise in GxP, QMS, and audit readiness; familiarity with Veeva Vault eQMS. WorkSetup: not specified.