Manager, Qa Operations Disposition

Genetix Biotherapeutics

Somerville, MA, United States
Base: $118,000 - $166,000 usd; bonus/equity: eligi...
On-site
Cgmp compliance and batch record review
External manufacturing partner collaboration
Lot disposition and material release
This role supports the release of externally manufactured drug products, viral vector materials, and qualified starting materials used in Genetix Cell & Gene therapy programs

Job Summary

  • This role supports the release of externally manufactured drug products, viral vector materials, and qualified starting materials used in Genetix Cell & Gene therapy programs.
  • The position ensures incoming documentation packages meet internal quality standards and regulatory expectations while enabling timely product availability.
  • Genetix offers a comprehensive benefits suite including health insurance, employer-matched 401(k), paid parental leave, and tuition reimbursement.

Matching Summary

This role supports the release of externally manufactured drug products, viral vector materials, and qualified starting materials used in Genetix Cell & Gene therapy programs.

Salary

Base: $118,000 - $166,000 USD; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive health, life, disability, 401(k) match, and paid time off

Skills & Requirements

Must-have

  • cGMP compliance and batch record review
  • External manufacturing partner collaboration
  • Lot disposition and material release
  • Electronic quality system proficiency
  • Deviation investigation and CAPA support

Nice-to-have

  • Digitalized CGT process implementation
  • Operational excellence and efficiency drive
  • Cross-functional team leadership
  • Audit preparation and inspection readiness

Key Requirements

  • Bachelor's degree in STEM field
  • 7+ years regulated biopharma experience
  • Direct exposure to cGMP quality systems
  • Experience with CMOs/CDMOs
  • Proficiency with eQMS and LIMS

Work Rights

Not specified

Tailored Resume

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