Quality Manager

3 weeks ago


Framingham, United States The Fountain Group Full time

Core Responsibilities include: Investigating and writing deviations, laboratory investigations, CAPAs, Tasks, Effectiveness reviews, and audit observation responses. Define and implement CAPAs, tasks, and effectiveness reviews with the assistance of QC Management Manage / own CCRs and liaise with functional QC units for work execution Conduct self-inspection / audit walkthroughs Support internal / external audits and participate in and / or lead the completion of responses to internal / external audit related observations / CAPA Conduct gap assessments against external and / or other Sanofi sites audit observations and assist with plan development to drive remedial actions. Maintain a high level of personal compliance to the required company standards and industry best practices Provide expertise during procedure / SOP revision process and function as DCR approver for department related SOPs, where required Partner with QC operations and manufacturing, where applicable, to support a culture of continuous compliance / improvement Assist in generating metrics at the required frequency to drive accountability and delivery of targets Requirements need to be quantifiable. Bachelor's Degree in science or technical field 6 years' of experience in biopharmaceuticals or related industry working in a regulated, GMP environment Or Master's degree and a minimum of 3 years' experience working in a regulated, GMP environment. #J-18808-Ljbffr


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