Challenge
A long-running multi-product API site, after a new GM's review, halted production due to systemic quality issues across processes and systems.
Approach
We led third-party audits and grouped thousands of findings into 26 prioritized workstreams(CAPA, deviations, CSV, cleaning, maintenance, analytical methods, lab management, etc.). For each workstream, we deployed internal leads paired with external SMEs, established remediation plans and evidence-archiving protocols, and provided PMO and specialist support where needed.
Impact
Within ~18–24 months, the program closed all but one finding, restored production with sustainable controls, and shifted site culture toward quality (some workforce changes and training were required).
