Senior Manager/Associate Director, Quality Assurance, GCP
Listed on 2026-09-14
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Healthcare
Medical Science -
Quality Assurance - QA/QC
Role
Senior Manager/Associate Director, Quality Assurance, GCP at Xenon Pharmaceuticals, supporting early-phase clinical programs (pre-Phase
3).
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.
RequirementsBachelor'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.
High Valuesupporting early-stage clinical development, GCP/GLP compliance, clinical trial oversight, experience with regulatory inspections, preferably in neuroscience or neurotherapeutics.
Work Setuphybrid Boston-based (Needham), remote considered for exceptional candidates; minimal travel required.
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