Challenge
A clinical-stage pharmaceutical company needed a seasoned leader to manage the QA team and bridge a leadership gap to meet corporate quality commitments.
Approach
Scimitar deployed an Interim Head of QA to establish a data-driven decision framework and oversee the continued development of the Quality Management System (QMS). The lead implemented core procedural documents and a robust CAPA management system while driving a comprehensive inspection readiness program to prepare for pre-approval inspection.
Impact
Transformed the quality function into a strategic, inspection-ready asset by developing a fit-for-purpose QMS and driving key Quality decisions. This initiative helped ensure organizational compliance with GxP standards, successfully matured the QMS architecture, and mitigated risk ahead of critical health authority inspections.
