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Pfizer

Quality Assurance Manager

Pfizer, Groton, Connecticut, us, 06349


Quality Assurance ManagerSummary:You will be a proactive partner with the external supply business lines, clinical product development teams, maximizing the contribution of Global Quality Operations with our external contract vendors. You will be the Vendor Point of Contact responsible for the quality management of approximately 25 contract manufacturers, packager, contract test laboratories, and supply partners globally. As a Quality Manager, you will focus on developing relationships, independently negotiating, developing and communicating Pfizer quality requirements with contract vendors. Your expertise provides quality system leadership to operational teams, drives process improvement, advancing new concepts and methodologies that will make Pfizer ready to achieve new milestones and help patients worldwide.Responsibilities:Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the DepartmentContribute to Quality Assurance by undertaking a variety of roles or assignments to further develop internal processes and peopleAssess the operations executed at the supplier for their adherence to regulatory requirements, Quality Agreement requirements and Pfizer expectationsConduct quality reviews and report on results or defined quality analytics to in-country Medical Management, Platform Lines and Regional Medical Quality group, as appropriate.Provide project support with current Good Manufacturing Practices to clinical supply packaging operationsProvide guidance on procedures and training necessary to be in complete compliance with current GMPsQualifications:Bachelor's degree preferred, or a minimum of 5+ years of experience in lieu of a degreeVendor Quality Management experience in the Pharma industrycGMP experienceProficient with Microsoft Office productsStrong relationship building skillsNegotiation experience preferredAuditing experience preferredExperience with SAP preferredRate/Location:$46 - $51 per hourThis is a hybrid role in Groton, CT; candidates will be required to report onsite 2-3 days per week

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