Teams at Replimune

Provide QA oversight for GMP manufacturing and testing, perform batch reviews to support product release, maintain and improve quality systems (change control, deviations, CAPA), lead audits and vendor oversight, ensure compliance with MHRA/EMA/FDA, train staff, and manage QA documentation and metrics.

Lead development, qualification, validation and transfer of analytical methods for drug substance and product under ICH and cGMP. Support release, stability, QC, process development, CMC filings, and coordinate CRO/CMO analytics. Troubleshoot methods, supervise assay staff, and provide cross-functional AD representation and regulatory support.

Support day-to-day Quality Assurance operations within a GMP environment: perform batch reviews, assist QMS activities (change control, deviations, CAPA), review and approve SOPs/validation and testing records, conduct root cause analyses, perform compliance walkarounds, track QMS metrics, manage controlled documentation, and liaise with internal teams and external vendors to ensure regulatory compliance.