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    Senior Compliance Auditor - Cambridge, United States - EPM Scientific

    EPM Scientific
    EPM Scientific Cambridge, United States

    3 weeks ago

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    Description
    Senior Compliance Auditor

    Role Description:
    Oversee and participate in audits, reporting on findings.
    Manage Quality Technical Agreements with critical suppliers.
    Conduct internal audits to meet GMPs, 820 standards, and company requirements.
    Lead and support supplier audits (onsite and remote) for GMP and regulatory compliance.
    Uphold the Supplier Management Program, including drafting and maintaining Quality Technical Agreements.
    Address and escalate compliance issues to the appropriate teams.
    Support the Supplier Management Team and medical device supplier project teams.
    Develop and revise Standard Operating Procedures (SOPs).

    Role Requirements:
    Bachelor's degree or equivalent with 10 years of experience in a pharmaceutical/biotech quality unit.
    5+ years of experience as a qualified auditor, assessing supplier compliance with cGMP, QSR, and ICH regulations.
    Strong understanding of relevant FDA regulations/guidance and ICH Guidelines.
    Proven ability to independently plan, execute, and report audits.
    Experience in cell manufacturing/biologics, medical devices, and/or software quality is a plus.
    Familiarity with Good Clinical Practice (GCP) and ICH E6 is preferred.
    This role is hybrid (Mon, Tue, Thu onsite) with 30% travel within Massachusetts and Michigan.

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