Senior Director Quality Assurance

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

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