Quality Assurance Manager

2 weeks ago

Groton, United States Integrated Resources, Inc Full time

Job Title: Quality Assurance Manager

Job Location: Groton, CT (Hybrid)

Job Duration: 18 Months +

Pay range: $48.87/Hr. on W2

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’s 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.

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

Schedule: Required Onsite 2-3 days per weeks. Support US and UK time zones.

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