Senior Quality Engineer, Digital System QA

Company: Insmed Incorporated

Job Overview

The Senior Quality Engineer, Digital System QA at Insmed Incorporated provides quality oversight for GxP computerized systems throughout their lifecycle, ensuring compliance with FDA, EMA, and ICH regulations.

Responsibilities

• Support the implementation and management of digital systems for clinical trials and quality control
• Focus on data integrity and validation
• Review validation deliverables, change controls, deviations, and CAPAs
• Ensure compliance with regulations like 21 CFR Part 11

Requirements

• Bachelor's degree
• 5+ years of QA/Validation experience in a regulated industry