Sr. Manager, Quality Control

Replimune is seeking a Sr. Manager, Quality Control to oversee the work of direct reports, manage QC laboratory and equipment, and lead method transfer and validation activities. The role requires experience in GLP/GMP, leadership, and communication skills.

Requirements

• Manage direct reports
• Lead QC assay transfer/validation activities
• Set-up GMP compliant QC processes
• Review and approve QC test data and CoA
• Write, review and QC approve change controls, CAPA, deviations, protocols, reports forms and templates
• Lead investigations for OOS and OOT results
• Participate in regulatory inspections and submissions
• Oversee and manage maintenance of QC laboratory and equipment
• Lead QC laboratory equipment introduction and participate in equipment validation
• Oversee sampling and storage of QC samples and maintain inventory
• Coordinate shipping and receipt of QC samples and other QC related material
• Training others within department on methods and processes in accordance with GMP practices
• Become SME for QC methods, monitor method performance and lead troubleshooting/method optimisations as required
• Interact within internal as well as across other functional group to communicate QC requirements
• Deputize for other roles during periods of absence or when responsibilities have been delegated
• Perform QC testing following Standard Operating Procedures (SOPs)
• Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP)

Benefits

• Competitive total rewards program