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Quality Assurance Lead
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- This includes the new GMP Phase 1 clinical production facility in Marlborough MA with the focus on novel modalities including allogenic stem cell, cell and gene therapy, extracellular vesicles, and using next generation manufacturing methods.
- As the Quality Assurance Lead, you must possess a strong background in Quality Systems, Document Control, Supplier Quality, and Validation within the biotech industry.
- You will lead the implementation and maintenance of the Quality Management System (QMS) tailored to the biotechnology industry, ensuring compliance with regulatory standards such as FDA, EMA, and ICH guidelines.
- One of your tasks will be to drive continuous improvement initiatives within the QMS, including CAPA, change control, and risk management processes.
- Demonstrated experience with Quality Systems, Document Control, Supplier Quality, and validation activities.
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