Tech Stack

Description

In this role, you will lead the quality system team responsible for GxP training management, ensuring compliance with regulatory requirements and driving continuous improvement. You'll partner with key stakeholders to monitor quality systems, develop training programs, and support audits and inspections.

Requirements

• BA/BS in Biological Sciences, Chemistry, or related field
• Minimum 10 years Pharma/Biotech QA experience in GxP environment
• Experience developing and implementing GxP quality systems
• Direct experience with Veeva QualitySuite electronic platforms (QualityDocs, Training, QMS)
• Excellent knowledge of GxP requirements and ICH guidelines

Responsibilities

• Lead quality system team for GxP training management and continuous improvement
• Partner with stakeholders to evaluate and monitor quality system health
• Oversee companywide GxP training programs aligned to job functions
• Analyze quality data and recommend process improvements
• Provide leadership, mentorship, and coaching to the GxP Training team