Most of the projects that I have worked on, which have had a big scope and long timelines, has followed a format in which one person is the Project Manager and underneath the project manager are a bunch of Project Leads from different departments. The Project Manager usually has a high overview of the details of what is going on within the project that is usually reported to him/her through the Project Leads. The Project Leads are basically the leaders or head of whatever department in the supply chain that is involved with the project. Most of the major projects I’ve personally worked on are driven by Regulatory (UDI / BSI), therefore they are the project managers. Then the Project Leads are people within Manufacturing Engineering, Supply Chain, and Finance. Most of the people doing the executing of the project are actually the people who work beneath or alongside the Project Leads such as the analyst, specialist, or lower level engineering roles. When it comes time to reporting to upper management the ins and outs and anything good or bad, the Project Manager usually ends of taking a lot of the heat.

When I was working on BSI (basically the FDA of Europe), this project pertained to meeting certain European regulations and the Regulatory people within the company had weekly meetings essentially with the BSI auditors and upper management. Therefore, it makes sense that these people would be the Project Managers. Ideally, whichever department has the most at stake for the project, should take ownership of it.