Senior Manager, GCP Quality Assurance

Role: The GCP/Clinical Quality Assurance Lead at Madrigal ensures clinical trial compliance and quality for biopharma, focusing on GCP regulations, industry standards, and global regulatory requirements. Responsibilities include developing and maintaining clinical quality systems, overseeing vendor management and audits, managing quality events and CAPAs, and supporting inspection readiness across R&D functions. The role requires reviewing clinical documentation, leading quality investigations, and contributing to process improvements. Requirements: minimum 7 years in clinical QA within biopharma or CRO, including vendor and site auditing, along with 3-5 years in clinical operations managing cross-functional studies. GCP expertise is essential, with GVP/GLP knowledge a plus. Qualifications include a BS in a relevant scientific discipline and experience supporting health authority inspections. High-value details: focus on GxP compliance, vendor oversight, audit management, and inspection readiness in a global biopharma environment. The role reports to the Senior Director, GCP Quality, and involves cross-functional collaboration. Work setup details are not specified, but the position is dedicated to ensuring high standards in clinical trial conduct, primarily in the late stages of development for MASH therapeutics.