Sr. Quality Engineer, Digital System QA

Company Name

Insmed Incorporated

Job Description

The Sr. 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

• Supporting data integrity, validation, and inspection readiness.
• Partnering with IT and business teams.
• Reviewing validation deliverables.
• Ensuring compliance with 21 CFR Part 11 and Annex 11.
• Participating in change control, deviations, and CAPAs.

Requirements

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