A BDN client has its 1st FDA inspection and is looking to have a GMP Inspection Readiness expert to be on hand and driving the activities to close the gaps in the assessment that has already been completed. This person will need to have prior experience with PAI Audits, FDA Inspections, and GMP Compliance Activities. This client would like to see candidates with experience working with smaller, start-up type companies going through their first Inspection (a huge plus, not a must). This individual will be reporting to the Lead of Inspection Readiness as the driving force to execute and report on the progress made. The Project Manager/GMP Role will need to drive the execution side of the project mostly but also the training, coaching teams, and reporting (metrics & dashboard) project milestones at a high level. He/she should be able to elevate any delays or concerns to stakeholders professionally to work through a problem and find a solution.