Job Details

*****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