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    Quality Assurance Manager - New York, United States - EPM Scientific

    EPM Scientific
    EPM Scientific New York, United States

    Found in: Appcast US C2 - 18 hours ago

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    Description

    Title: Manager, Site Compliance

    About the role: Step into a crucial role within a large medical device company as the Manager of Site Compliance. We are in search of an experienced leader to lead all site Quality regulatory compliance activities, play a pivotal role in maintaining the effectiveness of the Quality Management System (QMS), and ensure the effectiveness of internal and external audit programs.

    Key Responsibilities:

    • Lead the strategic development and implementation of the Internal and External Audit cGMP QA System for drug/device products.
    • Establish and manage a qualification/certification program for Internal/external auditors.
    • Collaborate with SMEs to conduct external audits on suppliers, laboratories, and third-party manufacturers.
    • Ensure timely completion of corrective actions stemming from internal or external audits, and evaluate the effectiveness of CAPAs.
    • Coordinate and chair monthly QMS Metrics Meetings and annual Management Review meetings to monitor the effectiveness of the Quality Management System (QMS).

    Qualifications:

    • BS/BA degree in a relevant scientific discipline
    • Minimum of 5+ years of relevant experience in Medical or Pharmaceutical Industry
    • 5+ people management experience
    • Veeva Vault experience
    • Experienced leading FDA or regulatory inspections
    • Preferred experience: Six Sigma Green Belt (ASQ), (CQA) / Conduct QMS audits against standards and regulations such as 21 CFR 210 / 211 / 820 and ISO 13485 / 9001
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