Vendor Manager-Quality Assurance

3 weeks ago

Groton, United States Integrated Resources, Inc ( IRI ) Full time

Title: Quality Assurance Manager


Location: Groton, CT (Hybrid: Required Onsite 2-3 days per weeks)


Support US and UK time zones


Duration: 18 months



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 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 various roles or assignments to 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.



Hard Skills:

1. Vendor Quality Management Exp. in Pharma industry

2. CGMP, not GCP

3. Project management

4. MS Office



Plus Skill:

1. Relationship building

2. Negotiation

3. Auditing

4. SAP



BS Preferred

(open to 5 + years' experience in lieu of degree)

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