![Barrington James](https://media.trabajo.org/img/noimg.jpg)
Director of Quality
2 weeks ago
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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