Backed by Khosla and Lux.
About the role
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH.
What they're looking for
- Bachelor’s degree in a scientific or operational discipline relevant to the life sciences or biopharma areas with 5+ years combined of experience in quality system management
- Non-degreed candidates with 7+ years combined of relevant GLP/GMP quality systems experience will be considered
- Knowledge of Quality Management Systems (QMS), CAPA processes, and audit procedures
- Familiarity with relevant regulations and standards (e.g., ISO, FDA, cGMP)
- Strong analytical, problem-solving, and communication skills
- Proficiency in using QA software tools and electronic Quality Management Systems (eQMS) is a plus
More about this role
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
At eGenesis, our core values —innovation, collaboration, compassion, resilience, and passion—are at the center of how we work. We engineer hope and bring passion to everything we do. We collaborate and learn from one another, combining diverse expertise to tackle complex challenges. We innovate boldly, pushing boundaries and science to new heights. where no pig organ has gone before. With resilience, we navigate challenges and celebrate progress together. And in all we do, we lead with compassion—for our patients, our people, and our pigs.
POSITION SUMMARY
The Senior Quality Systems Specialist will be supporting the QA team to implement...
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