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Obsidian Therapeutics is pioneering engineered cell and gene therapies, with a lead program in clinical development for metastatic melanoma and non-small cell lung cancer using their proprietary cytoDRiVE® platform.
You will join the Technical Operations team in Bedford, MA as a Quality Systems Manager, responsible for owning, maturing, and modernizing scalable quality systems as the company advances its first clinical-stage autologous cell therapy program. This is a key contributor role within Quality Systems & Compliance.
Core responsibilities include:
- Manage the Quality Management System (QMS) and serve as process owner for critical quality processes: Change Control, Product Complaints, Deviations, Corrective and Preventive Actions (CAPA), Vendor Notifications, and Quality Management Review (QMR)
- Implement Obsidian's electronic QMS (eQMS) platform
- Drive modernization and scalability of quality systems to support clinical development and eventual commercialization
- Collaborate with cross-functional teams including Research (Cambridge) and Technical Operations (Bedford)
- Ensure compliance with regulatory requirements for cell and gene therapy development
You will be part of a highly collaborative culture at a clinical-stage biotech company with experienced leadership, field-leading advisors, and best-in-class partners. The company offers competitive salary, benefits, and stock option ownership.
Ideal candidates have strong background in owning and maturing quality systems, experience with eQMS implementation, knowledge of cell/gene therapy or regulated manufacturing environments, and ability to drive process improvements in a fast-moving clinical development setting.
