Sales closed a deal for just-in-time labeling on a clinical trial that would run for ten years: more than $30M of business for Thermo Fisher. The service didn't exist. There was no process, no team and no space to run it. I was pulled in once it had become an emergency.
Just-in-time labeling means study medication gets its final labels when an order comes in, not months ahead. The same stock can follow a trial as countries and protocols change, but only if the operation behind it is fast and fully compliant.
The first decision
Governance. I set up a daily steering committee with executives to fast-track decisions. Then everything ran in parallel: the business model, the operational process, hiring a Qualified Person and QC staff, and building a secondary packaging area that met regulatory standards. We planned the scale-up to follow the trial's needs.
What happened
Three months later the service was running. Process time went from 26 days to 5, and on-time delivery stayed above 99%. A reputational risk with a customer became a new service line.
What I took from it
A large organization can decide very fast when the information in front of it is built for the decision. And the team delivered a global service, closing the remaining gaps through sheer effort. It was intense.