Sr. Director, Head of Clinical Quality Assurance

Role: Senior Director, Head of Clinical Quality Assurance at Scholar Rock, leading GCP quality strategy and operations for biologics clinical development. Responsibilities: oversee clinical quality systems, vendor audits, inspection readiness, risk management, and quality metrics; serve as strategic partner to clinical, regulatory, and data teams; develop and mature GCP quality processes; ensure compliance in global late-stage trials. Requirements: BS/MS in scientific/healthcare field; 15+ years in biotech/pharma, with 10+ years in GCP quality, including leadership of Phase I–III biologics trials; deep knowledge of ICH-GCP, FDA, EMA, PMDA regulations; experience supporting biologics development and inspection readiness; strong vendor oversight and quality system design skills. Preferred: experience with late-stage biologics programs, regulatory inspections, and outsourced biotech models. HighValue: biologics, late-stage development, global trials, GCP compliance, inspection preparedness, vendor oversight, risk-based quality management. WorkSetup: not specified.