Quality Manager

2 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 theassistance of QC ManagementManage / own CCRs and liaise with functional QC units for work executionConduct self-inspection / audit walkthroughsSupport internal / external audits and participate in and / or lead the completion ofresponses to internal / external audit related observations / CAPAConduct gap assessments against external and / or other Sanofi sites auditobservations and assist with plan development to drive remedial actions.Maintain a high level of personal compliance to the required company standardsand industry best practicesProvide expertise during procedure / SOP revision process and function as DCRapprover for department related SOPs, where requiredPartner with QC operations and manufacturing, where applicable, to support aculture of continuous compliance / improvementAssist in generating metrics at the required frequency to drive accountability anddelivery of targetsRequirements 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 environmentOrMaster's degree and a minimum of 3 years' experience working in a regulated, GMP environment.


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