Teams at Replimune

Lead and oversee aseptic drug product manufacturing at a new cGMP facility, ensuring sterile operations, contamination control, environmental monitoring, batch record management, CAPA/investigation support, equipment maintenance, technology deployment, staff hiring and development, and regulatory interactions to achieve commercial readiness and compliance.

Perform cGMP/GLP QC analytical testing of raw materials, in-process, drug substance and final product per SOPs. Maintain QC systems, review data, support method qualifications, investigations (OOS/OOT), CAPA/change control, equipment validation, sample management, and training. Support audits, regulatory inspections, vendor interactions, and coordination with external testing labs to ensure GMP compliance.

Support and maintain GxP-aligned Quality Systems for multiple sites: manage controlled documents and archival, administer MasterControl and Veeva, handle Jira document requests, create training items, support audits, generate QMS metrics, and drive continuous improvement to ensure cGMP compliance and inspection readiness.