- 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.
- Assess the operations executed at the supplier for their adherence to regulatory requirements, Quality Agreement requirements and client 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.
- Vendor Quality Management Exp. in Pharma industry
- cGMP
- Project management
- MS Office
- Relationship building
- Negotiation
- Auditing
- SAP
- (open to 5 + years' experience in lieu of degree)
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Quality Assurance Manager - Connecticut, United States - Integrated Resources, Inc ( IRI )
Description
Title: QA Manager
Job Location: Groton, CT (Hybrid)
Job Duration: 18 Months
Hybrid: Required Onsite 2-3 days per weeks
Support US and UK time zones.
Job Description:
Hard Skills:
Plus Skill:
BS Preferred
