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  • Director Gmp Compliance - Munster - Regeneron Pharmaceuticals, Inc

    Regeneron Pharmaceuticals, Inc
    Regeneron Pharmaceuticals, Inc Munster

    1 month ago

    Regeneron Pharmaceuticals, Inc background
    Full time
    Description

    Job Title:

    DIRECTOR OF GMP COMPLIANCE & INSPECTIONS

    About the Role:

    This position requires a highly skilled individual to drive activities ensuring continuous Good Manufacturing Practice (GMP) compliance within Regeneron IOPS.

    The Director will lead cross-functional teams in building inspection readiness capabilities and educate the organization on compliance awareness.

    Key Responsibilities:

    • Serve as a thought partner to the GMP Compliance and Inspections leadership, utilizing strong critical thinking skills to address complex problems.
    • Lead proactive evaluations of site GMP compliance against current and emerging regulatory trends.
    • Define and implement systems and metrics for maintaining regulatory compliance across all operations.
    • Evaluate GMP compliance across all areas of the site, including procedures and processes.
    • Interface with customer/partner quality organizations and participate on internal committees/teams as required.
    • Provide advice and direction to other departments on quality and regulatory issues.
    • Benchmark leading practices and recommend improvements to ensure IOPS is inspection-ready at all times.

    Requirements:

    A BA/BS degree in Life Sciences or related field, along with 12+ years of relevant experience in the pharmaceutical or biotech industries, or an equivalent combination of education and experience.

    Estimated Salary: $170,000 - $200,000 per year.


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