Senior Director Quality Assurance - Santa Rosa - Barrington James

    Barrington James
    Barrington James Santa Rosa

    2 days ago

    $180,000 - $260,000 (USD) per year *
    Description

    *****EXCITING NEW OPPURTUNITY ******

    Director/ Senior Director - Quality Assurance

    We are partnered with a global biotech that is looking to expand their quality team by bringing in a director/senior director of quality assurance.

    Their position focus will be supporting the development, coordination and implementation of global pharmacovigilance regulations related to quality assurance activities.

    Key requirements-

    • 8-10 years of hands-on Global Pharmacovigilance experience within biotech/pharma environments
    • Proven track record supporting and leading FDA, EMA, and other global health authority inspections
    • Confident interacting directly with regulators and managing regulatory inquiries
    • Strong working knowledge of global GVP regulations and pharmaceutical quality standards
    • Experienced in conducting internal audits and maintaining an effective, inspection-ready QMS

    Responsibilities-

    • Ensure global PV compliance (FDA, EMA, ICH)
    • Lead risk-based PV audits, CAPA management, and metric trending
    • Drive inspection readiness and serve as QA lead during health authority inspections
    • Oversee PV deviations and maintain effective quality systems documentation
    • Provide PV training, regulatory updates, and cross-functional compliance support
    • Support EU QPPV, reporting activities, and product complaint oversight
    * This salary range is an estimation made by beBee
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