Senior Specialist, Quality Assurance Operations
enGene(1 month ago)
About this role
The Senior Specialist QA Operations at enGene provides quality oversight for external manufacturing partners (CDMOs) supporting clinical and commercial gene therapy products. The role sits within the Quality organization and is closely aligned with CMC, Quality Control, and Regulatory teams. It focuses on maintaining a strong quality partnership with CDMOs to support enGene’s late-stage genetic medicine programs. The position is based in Boston, MA and requires periodic travel to partner sites.
Required Skills
- Batch Record Review
- Issue Resolution
- Product Disposition
- Quality Oversight
- CAPA Management
- Change Control
- Risk Management
- GMP Audits
- Inspection Support
- Procedure Development
+7 more
Qualifications
- Bachelor's in Scientific Discipline
- Master’s in Scientific Discipline
About enGene
engene.comenGene is a biotechnology company focused on mainstreaming gene therapy by developing non-viral therapeutic approaches. Its lead investigational candidate, detalimogene, is being advanced for the treatment of non‑muscle invasive bladder cancer (NMIBC). The company’s stated goal is to reduce treatment burden and improve patient outcomes through a safer, non‑viral gene therapy platform. enGene positions itself to translate gene therapy into more widely accessible standard-of-care options.
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