Tech Stack

Description

You will lead internal audits of GCP systems and departments, managing the clinical audit program and overseeing CROs. You'll ensure compliance with GxP regulations, perform risk assessments, and support regulatory inspections, collaborating with cross-functional teams to drive continuous improvement in quality processes.

Requirements

• BA/BS in Biological Sciences, Chemistry, or related field
• 10+ years pharmaceutical/biotech experience with 5+ years GCP auditing including TMFs
• Familiarity with GCP, GLP regulations in US/EU and ICH requirements
• ASQ Certified Quality Auditor or equivalent
• Experience with Quality System electronic databases and Microsoft Office

Responsibilities

• Lead internal audits of GCP systems and departments, follow up on CAPA implementation
• Perform GxP internal audits, complete audit reports, and manage corrective actions
• Audit Trial Master Files (TMFs) for various programs
• Manage GxP vendor/supplier qualification and oversight
• Create and maintain the internal GCP annual audit schedule