Sr. Manager, R&d Quality

Genetix Biotherapeutics

Somerville, Massachusetts, USA
Base: $155,000—$170,000 usd; bonus/equity: equity ...
On-site
R&d quality management
Vendor qualification audits
Clinical study quality oversight
At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference

Job Summary

  • At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference.
  • This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.
  • Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience.

Matching Summary

At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference.

Salary

Base: $155,000—$170,000 USD; Bonus/Equity: Equity may be provided; Benefits: Full range including medical, dental, vision, 401k, unlimited PTO, parental leave

Skills & Requirements

Must-have

  • R&D quality management
  • Vendor qualification audits
  • Clinical study quality oversight
  • GCP compliance and inspection readiness
  • Audit scheduling and execution
  • CAPA and deviation investigations

Nice-to-have

  • Strong communication and stakeholder influence
  • CGT-specific clinical quality assurance
  • Chain-of-custody systems knowledge
  • Cross-functional collaboration
  • Risk-based audit scheduling

Key Requirements

  • 8-10 years gene therapy or biotech experience
  • 8-10+ years R&D quality experience
  • Experience auditing investigator sites and GMP vendors
  • Knowledge of FACT/JACIE requirements
  • Experience with GCP compliance and clinical trial oversight
  • Experience leading clinical deviations and CAPAs

Work Rights

Not specified

Tailored Resume

Cover Letter