Senior Manager/Associate Director, Quality Assurance, GCP

Role: Senior Manager/Associate Director, Quality Assurance, GCP at Xenon Pharmaceuticals, supporting early-phase clinical programs (pre-Phase 3). Responsibilities: serve as quality lead for clinical studies, develop and maintain Quality Plans, oversee risk assessments, and ensure compliance with GCP and GLP regulations; support regulatory inspections, audit programs, and quality oversight for GLP activities; collaborate with cross-functional teams to uphold quality standards. Requirements: Bachelor's in a scientific or health field, 8+ years of GxP QA experience (6+ in GCP), at least 3 years in a leadership role within pharma or biotech; deep knowledge of GCP and GLP regulations, experience with regulatory agencies (FDA, EMA, etc.), and strong audit and risk management skills. HighValue: supporting early-stage clinical development, GCP/GLP compliance, clinical trial oversight, experience with regulatory inspections,  preferably in neuroscience or neurotherapeutics. WorkSetup: hybrid Boston-based (Needham), remote considered for exceptional candidates; minimal travel required.