Senior Specialist, Manufacturing Technical Operations (Contract) 28190

Job description

Job Description This Senior Specialist in Manufacturing Technical Operations (MTO) is responsible for complete ownership of quality records including, but not limited to Deviations, Analytical Investigations, CAPAs, Change Controls, and Risk Assessments supporting cell manufacturing at our Boston site. The person in this role will drive cross-functional root cause analysis meetings and promote compliance best-practices to ensure timely and thorough completion and will focus on deviations. This includes all aspects of MTOs operational compliance support with emphasis on tracking and executing CGT initiatives, implementing MTO best practices and ensuring exceptional internal and external department collaboration and communication. This role will be pivotal for distributing and acting on metrics as well as supporting MTO intake and prioritization. This role is an on-site position based in our Boston location. This role requires a high-level of schedule flexibility to support our cell manufacturing clinical hours of operation and timelines. KEY RESPONSIBILITIES : - Lead, write and review deviations and investigations for Vertex Cell and Genetic Therapies (VCGT). Including the manufactu...