Quality Assurance Manager job in Groton

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Connecticut (CT), Groton

Job Code:	24-01271
Employer:	Aequor
Category:	QA
Location
Country:	United States
State:	Connecticut (CT)
City:	Groton
Post Date:	04/21/2024
Description
Job Description : 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 * quality requirements with contract vendors. Your expertise provides quality system leadership to operational teams, drive process improvement, advancing new concepts and methodologies that will make * ready to achieve new milestones and help patients worldwide. Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the Department. Contribute to Quality Assurance by undertaking a variety of roles or assignments to further develop internal processes and people. Assess the operations executed at the supplier for their adherence to regulatory requirements, Quality Agreement requirements and * expectations. Conduct quality reviews and report on results or defined quality analytics to in-country Medical Management, Platform Lines and Regional Medical Quality group, as appropriate. Provides project support with current Good Manufacturing Practices to clinical supply packaging operations. Provides guidance on procedures and training necessary to be in complete compliance with current GMPs. Intake Notes: Hard Skills: Vendor Quality Management Exp. in Pharma industry cGMP, not GCP Project management MS Office Plus Skill: Relationship building Negotiation Auditing SAP BS Preferred (open to 5 + years' experience in lieu of degree) Hybrid: Required Onsite 2-3 days per weeks, will need to be local to the Groton Site. Interview Process:** 1st: 1:1 interview (Virtual via Teams w/Camera on) 2nd: Panel (virtual via Teams w/Camera on) Strictly GMPs for this role, not GCP Hybrid: Required Onsite 2-3 days per weeks, will need to be local to the Groton Site.