Clinical / Scientific - Quality Assurance Manager - Chesterfield, United States - Pioneer Data Systems

    Pioneer Data Systems
    Pioneer Data Systems Chesterfield, United States

    2 weeks ago

    Pioneer Data Systems background
    Description

    Position Details:


    Our client, a world-leading Pharmaceutical Company in Groton, CT is currently looking for a Manufacturing Quality Manager to join their expanding team.


    Job Title:
    Manufacturing Quality Manager / Pharma Industry / Hybrid Work

    Duration: 19 months contract, extendable up to 36 months


    Location:
    Groton, CT


    Hybrid:
    onsite 2-3 days / week


    Note:
    The client has the

    right-to-hire

    you as a permanent employee at any time during or after the end of the contract.

    You may participate in the company group

    medical insurance

    plan


    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 Pharmaceutical 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 Pharmaceutical 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 Pharmaceutical 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:

    • Vendor Quality Management Exp. in Pharma industry
    2. 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)


    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)


    Comments :
    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.


    Minimum Education:
    Bachelors Degree
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