Vendor Manager-Quality Assurance - Groton, United States - Integrated Resources

    Integrated Resources
    Integrated Resources Groton, United States

    4 weeks ago

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    Description

    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)