Top-3 Bio-pharmaceutical company quality remediation
Our client sought to remediate quality issues at a plant responsible for producing > $6B revenue worth of active pharmaceutical ingredients and intermediates. Scimitar partnered across all functions to manage a budget of >35M, more than 100 consultants, and site staff to achieve successful audits by several global health authorities.
Results included developing robust tracking and reporting processes and tools to ensure the closure of >1000 quality gaps identified by a 3rd party quality oversight consulting firm and global health authorities during site inspections, implementing the site’s first cross-functional governance team to manage production commitments while simultaneously executing manufacturing and equipment related remediation activities, and establishing plans to implement portfolio management, cross-functional governance, and business process management.
Most importantly, we enabled our client to successfully avert a consent decree and protect their global quality reputation, as well as, prevent patient level stock-out of critical medicines, and drive significant cultural changes by engraining a mindset of quality at the site to ensure lasting change.