A BDN client is starting the final phase of clinical trials and has both Pharmaceutical and Device elements to the product. This consultant needs to be a Subject Matter Expert with Quality Management Systems with a small start-up environment. They do not want large Pharmaceutical or Medical Quality Systems that can be too cumbersome to work within. They are hoping to have an expert work with there team to build the initial framework of the systems. They would like this person to assess the systems and put a framework system that allows them to build out to cover the full range of products. Also, they have implemented a new PLM system (Arena) that should be going live very soon. The candidate must have a small startup QMS experience and be able to demonstrate how they assessed the criteria, how they developed the framework, and what plan was put in place to achieve compliance. He/she must have combination product quality systems experience. The client is a virtual company with no onsite production and managed all by 3rd parties. Prior experience around this would also be highly preferred. The consultant will need to have the ability to draft SOPs to close the QMS gap and have experience with the creation of fully integrated QMS, taking existing SOPs, WI's, etc. and combining with new documentation (complete vision of what system should be).