Perform pre-campaign readiness assessments to confirm completion of requirements prior to manufacturing.
Provide oversight of the CMOs quality management system (QMS) to confirm adherence to the quality technical agreements.
Provide effective oversight of manufacturing operations at the CMOs including on the floor support (at the drug substance CMO in Frankfurt, Germany) as needed. Actively observe manufacturing operations for drug substance on a routine basis to ensure compliance to cGMPs.
Review and approve CMO batch records, validation reports, test data package, deviations, and change controls.
Evaluate and investigate manufacturing and lab deviations. Provide direction and recommendation as to future course of action.