Backed by GV.
About the role
A key contributor within Quality Systems & Compliance, you’ll implement Obsidian’s eQMS and serve as process owner for critical quality system processes including Change Control, Product Complaints, Deviations, CAPA, Vendor Notifications, and Quality Management Review, as we advance our first clinical stage autologous cell therapy program targeting solid tumors.
What they're looking for
- Bachelor's degree and 6+ years of experience in QA within clinical late stage biopharmaceutical environments
- 3+ years of direct process ownership or administration of quality systems, including change control
- Successful experience leading or playing a significant role in implementation of an eQMS
- Management of systems such as Veeva, MasterControl, TrackWise, or equivalent platforms
- Strong working knowledge of FDA, EU GMP, ICH, and applicable GxP regulations
- Excellent planning, coordination, and time management skills
More about this role
About Us …
Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our cytoDRiVE® technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in clinical development for the treatment of patients with metastatic melanoma and non-small cell lung cancer.
We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our Research team is based in the heart of Cambridge, MA, and Technical Operations team is based in our purpose built facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
We are looking for a highly motivated Quality Systems Manager/Senior Manager, with a strong background in owning, maturing, and modernizing scalable Quality Systems.
A key contributor within Quality Systems & Compliance, you’ll implement Obsidian’s eQMS...
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