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    Director of Quality - New York, United States - Rbw Consulting

    Rbw Consulting
    Rbw Consulting New York, United States

    3 weeks ago

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    Description

    Job Title:
    Director of Quality (Sterile Products)

    RBW Consulting are partnering with a leader in pharmaceutical manufacturing, specializing in sterile products. They are committed to quality, compliance, and patient safety, providing products to the Pharmaceutical industry.


    Position Overview:
    We are seeking a passionate and accomplished

    Director of Quality

    to lead our sterile products division in the United States.

    Your role will be critical in ensuring that all manufacturing activities comply with the Manufacturing Quality Assurance concept developed by the Competence Center Manufacturing Quality (CC MQ).

    You will collaborate closely with colleagues globally, including other Competency Centers responsible for Microbiology & Aseptic Technique and QC Standards.

    Your responsibilities will extend to overseeing Laboratory Quality Assurance (LQA) activities as outlined in the global annex.


    Responsibilities:
    Acts as an ambassador for Senior Management's vision of the desired Quality Culture behaviors.
    Contribute to planning and executing the MQA / LQA concept.
    Develop standards for MQA / LQA activities to encourage alignment across regional sites and USSS.
    Implement best practice standards established by Competency Centers throughout our organization.
    Establish MQA / LQA touchpoints throughout the entire manufacturing process, ensuring oversight of drug testing.
    Prioritize global SOP implementation at regional sites.
    Monitor KPIs such as Right First Time (RFT), investigation timeliness, and 28-day batch release.
    Weekly monitoring of global complaints for signals and trends.
    Conduct formal and content-wise checks of Periodic Quality Reports.
    Participate in the annual review of MQA / LQA activities' efficiency and impact.
    Undertake additional activities based on inspection readiness or results, as directed by Senior Management.


    Requirements:
    Accomplished quality leader with

    10+ years

    of relevant experience in pharmaceutical manufacturing operations.
    Thorough knowledge of

    cGMPs, ICH guidelines, and other applicable standards .
    Proven leadership ability as an influencer.
    Bachelor's degree required; advanced degree in science or engineering preferred.
    Effective collaboration with NAM manufacturing and MQA teams.
    Demonstrated understanding of manufacturing system technology and the ability to establish a sustainable quality management system partnership.
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