Manager, Quality Systems

Genetix Biotherapeutics

Somerville, Massachusetts, USA
$117,000 - $166,000; bonus/equity: eligible for an...
On-site
Quality management system
Complaint and recall programs
Quality metrics reporting
The Manager, Quality Systems is responsible for overseeing key elements of the Quality Management System (QMS) that support manufacture, and release of gene therapy products

Job Summary

  • The Manager, Quality Systems is responsible for overseeing key elements of the Quality Management System (QMS) that support manufacture, and release of gene therapy products.
  • Responsibilities include managing complaint and recall programs, ensuring accurate Quality Metrics reporting, driving closure of QMS records, and supporting continuous improvement initiatives.
  • Genetix offers a comprehensive and competitive benefits suite including health insurance, 401(k) matching, flexible time-off, and tuition reimbursement.

Matching Summary

The Manager, Quality Systems is responsible for overseeing key elements of the Quality Management System (QMS) that support manufacture, and release of gene therapy products.

Salary

$117,000 - $166,000; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive benefits suite

Skills & Requirements

Must-have

  • Quality Management System
  • Complaint and Recall Programs
  • Quality Metrics Reporting
  • SOP lifecycle management
  • Electronic QMS platforms

Nice-to-have

  • Curative gene therapies
  • Radical care
  • Continuous improvement initiatives
  • Cross-functional leadership

Key Requirements

  • Minimum 5 years of experience
  • Bachelor's or Master's degree
  • Experience with electronic QMS platforms (e.g., Veeva Vault)
  • Strong communication skills
  • Problem-solving skills

Work Rights

Not specified

Tailored Resume

Cover Letter