• Build a digital database for Innovation & Development, capturing QA-relevant project data and lead assignments.
  • Support the transition and maintenance of the Quality System, ensuring compliance and documentation readiness.
  • Define and implement a standardized Change Control (CC) process for MBX and other biosimilars, including a Quality SharePoint and work instructions.
  • Design a scalable digital workflow for requesting and tracking GMP and registration documentation for biosimilar submissions.
  • Create a country-specific Quality requirements database covering testing, transport validation, notifications, and QA obligations.
  • Perform stability data sanity checks, identify gaps across markets, coordinate remediations, and ensure proper archival of data packages.