Director of Quality

2 weeks ago


New York, United States Barrington James Full time

Job Overview: I’m seeking an experienced Quality Director for an innovative cell therapy client. This pivotal role involves leading the Quality Management program ensuring compliance with FDA regulations & supporting new product launches.

Job Responsibilities: You will be responsible for ensuring compliance with FDA cGMP and cGTP regulations. The Quality Director will participate in the design and implementation of master process records & review of resultant batch process records You will oversee audits, document control, process control & coordinate quality agreements with external partners. You will be responsible for contributing to Drug Master Files (DMF) and IND applications to the FDA. Responsible for investigating deviations and non-conformances.

Job Requirements: Master’s degree in Science or related field with 5+ year’s experience in quality management You should have strong working knowledge of quality metrics and relational databases like Master Control. As the Quality Director you should have previous track-record with product launches and supporting health authority inspections Knowledge of regulatory requirements for cell and gene therapy products and clinical trials.

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