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Quality Improvement Manager

Company: Aerotek
Location: Basking Ridge
Posted on: January 15, 2022

Job Description:

Description:Global Development Quality Improvement Manager will work with Global Development Quality Improvement team to ensure that Global Development Processes and Procedures are followed, and that any Process Deviations are investigated and documented with the Quality Management System. The Global Development Quality Improvement Manager will also manage Corrective or Preventive Actions (CAPA) within the Quality Management System. They will partner with other members of the Global Development Quality group to identify trends through metrics in order to diagnose and remediate systemic quality issues, and will serve as a core member of Continuous Improvement initiatives.Liaise with Global Development Process & Procedures Team to proactively identify opportunities to streamline and strengthen Global Development processServes as GCP/GVP SME when SOPs are written or revisedManage Quality Events and Actions (Process Deviations, CAPA) within a regulated Quality Management SystemRepresent GCP/GVP expertise on cross-functional teams for related process improvements resulting from new/revised regulations or guidanceLeads cross-functional rapid response teams for identified GCP/GVP process violations needing immediate remediation.Work closely with Regulatory Intelligence team to identify changes in global regulations affecting current Regeneron processes as they relate to GCP/GVPInterfaces: Global Development Systems, IT Validation, SOP & Process team; Inspection teams; functional process owners, and Global Development Process improvement leadsAdditional Skills & Qualifications:Bachelors degree ( Masters degree preferred) with 5-7 years of relevant industry experience (Level commensurate with experience)> 5 years experience working in either a clinical compliance group, QA Quality Management/Quality Risk Management function, or Clinical Development with expertise and/or transferrable skills with Good Clinical Practice and Regulatory Inspections.Demonstrated experience and leadership on Continuous Improvement or Quality Improvement efforts (GCP Quality Improvement preferred)Experience Level:Expert Level About Actalent:Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Newark , Quality Improvement Manager, Executive , Basking Ridge, New Jersey

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