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Chesterfield

    Quality Assurance Manager - Chesterfield, United States - LanceSoft

    LanceSoft
    LanceSoft Chesterfield, United States

    3 weeks ago

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    Description

    Job Description:
    Repost Please DO NOT submit previously actioned candidates, they will automatically be disqualified) 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
    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 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 *** 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.


    Intake Notes:
    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)

    Hybrid:
    Required Onsite 2-3 days per weeks, will need to be local to the Groton Site. Support US and UK time zones.


    Interview Process:
    1st: 1:1 interview (Virtual via Teams w/Camera on) 2nd: Panel (virtual via Teams w/Camera on)

    Position Comments visible to Supplier:
    Repost Please DO NOT submit previously actioned candidates, they will automatically be disqualified) Strictly GMPs for this role, not GCP

    Hybrid:
    Required Onsite 2-3 days per weeks, will need to be local to the Groton Site. Support US and UK time zones.
    Rate Card Work Location is irrelevant.
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