Principal Associate II, Quality Systems

Role: Senior Quality Systems Specialist supporting GxP activities related to electronic Quality Management Systems (eQMS) at Replimune, focusing on compliance, system optimization, and inspection readiness. Responsibilities: lead process improvement projects, serve as subject matter expert for Veeva Quality applications and MasterControl, author and review quality documentation, generate quality metrics, support audits, and manage system administration and validation activities. Collaborate cross-functionally across manufacturing, quality, and regulatory teams to ensure GxP compliance. Requirements: Bachelor's degree with at least 7 years of experience in regulated biopharma environments, extensive Veeva QMS administration expertise, knowledge of FDA, EU, ICH GxP standards, and familiarity with GMP manufacturing operations. Preferred: advanced degree, experience with MasterControl, and supporting commercial manufacturing. High-Value: focus on quality system oversight within a biologics/gene therapy setting, supporting regulatory inspections and validation activities, with a hybrid onsite requirement in Framingham, MA.