Quality Assurance Manager in Groton, CT

  • Title: Quality Assurance Manager
  • Code: RCI-30996-1
  • RequirementID: 117280
  • Location: Groton, CT 06340
  • Posted Date: 04/19/2024
  • Duration: 19 Months
  • Salary ($): 47.37 - 48.88 per Hourly
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  Job Description

Hybrid: 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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