Data Scientist | About | Lumicell

Lumicell is seeking a highly motivated Pharma Quality Assurance Manager to work in a dynamic, fast-paced start-up environment on a combination drug-device product. Lumicell is developing a breakthrough surgical guidance technology platform consisting of a proprietary drug that is activated by the micro-environment of cancerous tumors, a custom fluoroscope that allows a surgeon to visualize activated drug, and a software system that gives a real-time prediction of tissue likely to be cancerous. This is an exciting opportunity to join a company that has received excellent press and generated promising clinical data while still in its early development.

The Pharma Quality Assurance Manager will lead the development of corrective action plans and monitor implementation. This position will contribute to the overall development, implementation and execution of quality systems in support of the drug manufacturing.

The Pharma QA Manager role consists of oversight of all Quality and compliance aspects of a pharmaceutical program as part of a combination medical device. This includes exposure and fluency with Quality Management Systems and requirements, supplier quality maintenance, review and approval of Deviations and CAPA, release of clinical product, and oversight of suppliers using cGMP best practices. Also, knowledge of clinical quality and global GCP standards is an asset. Important elements of this role also include: Investigation of Production, Incoming Quality, Chemistry, Microbiology, Engineering Validation, and other personnel necessary to complete the investigation