Our client is a CMO/CDMO for various types of Medical Devices (class II mostly). There are around 10 manufacturing plants that are in queue/process of launching MasterControl. The project is requiring an experienced Program/Project Manager to assist with PM-efforts. They do NOT need a MasterControl SME nor a PM to create workflows; instead, the client needs someone to manage and oversee eDoc creation, structure of governance and policies on creating workflows. The PM will begin the project by getting familiar with 2-3 current program managers to get acclimated to IT architecture, business flows for modules they are beginning, etc. Additional responsibilities will include (but not limited to): reviewing deliverables, scheduling meetings, coordinating summary reports, following up with internal/external members as needed, coaching/advising SME’s, managing rehearsals & data migration, advising IT on debugging, creating or reviewing policies (work instructions), ensure eForms are collected/stacked & governance of creation of eForms and MasterControl data processes are in place, and building/reviewing process flows. This will be a matrix working environment where the consultant will be working closely with SME at the plant, IT Senior Management, a document control contact, etc. The selected resource will need to work well independently as someone who can ensure scope of documents are in place, manage governance and set workflows. This is an initial 6-month contract, however, there are around 10 more sites needing to be launched which would provide more work for the ideal candidate.
Prior proven experience as a PM for MasterControl launch projects as well as strong knowledge of ISO 13485 / 45001, Medical Devices (at least Class II), ERP/SAP.
Remote: MasterControl PM (232082)