Teams at Replimune

Provide on-floor quality oversight for Drug Substance, Drug Product, and QC operations to ensure cGMP/GDP compliance. Perform batch record and quality record reviews, walkthroughs, inspections, deviation support, and escalate issues. Support audits and collaborate cross-functionally to maintain an inspection-ready, quality-focused environment.

Lead development and oversight of quality assurance systems for clinical and post-market pharmacovigilance and medical affairs. Ensure GCP/GVP compliance, inspection readiness, vendor oversight, regulatory interactions, KPI/KQI metrics, training, risk-based quality strategies, and cross-functional process improvement to protect patient safety and data integrity.

Lead development, implementation and maintenance of GxP-compliant quality systems (ICH Q10) including document control, training, change control, deviations, CAPA, metrics and inspection readiness. Manage eDMS (MasterControl), drive continuous improvement, support inspections, and lead the international quality systems team while partnering across functions and sites.