Integrated Resources, Inc ( IRI )
Quality Assurance Manager - GMP
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:1. Vendor Quality Management Exp. in Pharma industry2. cGMP, not GCP3. Project management4. MS Office
Plus Skill:1. Relationship building2. Negotiation3. Auditing4. SAP
BS Preferred
Groton, CT