Job Description

Insmed seeks a QMS Specialist to oversee quality management system activities and regulatory compliance for its Gene Therapy program in San Diego. The role involves managing documentation, change controls, deviations, CAPAs, training administration, and supporting inspection readiness.

Responsibilities

• Oversee completion and review of QMS records including Change Controls, CAPAs, Deviations, and Periodic Reviews for Gene Therapy
• Manage Learning Management System training administration tasks and monitor training curricula compliance
• Provide QA review and ensure completeness and compliance of quality documentation to cGMP standards
• Compile quality metrics for trending and communicate findings in Quality forums
• Support Change Control Committee activities, inspections, and audit readiness efforts

Requirements

• Bachelor's degree in Chemistry, Engineering, Life Science, or related field
• 6+ years Quality Assurance experience in pharmaceutical or medical device sectors
• Direct experience with Change Controls, Document Control, Deviations, CAPAs, and Effectiveness Checks
• Knowledge of cGMP regulations for pharmaceutical products
• Proficiency with electronic document management systems and Microsoft Office suite
• Experience analyzing data trends using Excel or Minitab
• Strong project management skills and attention to detail

Compensation: $81,000–$103,000 annual

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