Required Onsite 2-3 days per weeks, will need to be local to the Groton Site.
Support US and UK time zones.
Strictly GMPs for this role, not GCP
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)
- 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 Client 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 Client 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 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.
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