Tech Stack

Description

You will lead internal and external GMP/GxP audits, manage vendor quality programs, and ensure compliance with regulations. Your work supports the development of novel cancer therapies and prepares for regulatory inspections.

Requirements

• BA/BS in Biological Sciences, Chemistry, or related field
• 10+ years pharmaceutical/biotech experience with 5+ years GMP auditing experience
• Familiarity with US/EU GMP, GxP regulations, and ICH requirements
• ASQ Certified Quality Auditor or equivalent
• Ability to travel up to 25%

Responsibilities

• Lead internal audits of systems and departments to GMP/GxP regulations and follow up through CAPA implementation
• Perform GxP internal and external audits, complete audit reports, and track corrective actions
• Oversee GxP vendor/supplier program management, risk assessments, and quality agreements
• Maintain annual audit schedules and update SOPs and compliance tools
• Support regulatory inspections and represent Quality at cross-functional meetings