Director of Quality

COMPANY:

MIT start-up streamlining the engineering of a wide array of human and human-derived cells for use in next generation cell therapies.

LOCATION:

Cambridge, MA

TITLE:

Director of Quality (title dependent on experience)

TYPE:

Full-time, permanent

ROLE RESPONSIBILITIES:

This individual will be responsible for leading the strategy development and execution of the QMS. The Director of Quality will coordinate Quality certifications, accreditations, validations, licensures, needed for cell and gene therapy. Other responsibilities include:

• Support the management team in providing leadership, oversight, and progress reporting of QA/QC activities within development and commercialization projects.
• Provide Quality support for design and integration of IT and Software systems, such as experimental database, Inventory Management, and LIMS systems.
• Build or modify QC programs, and then perform/oversee the QC activities of the operation(s) such as setting up and managing the incoming statistical sampling/QC plans for raw materials.
• Support the development of Test Methods.
• Develop/perform FMEAs, CAPAs, and other Risk Management methods.

CANDIDATE REQUIREMENTS:

• BS Degree
• Has built and/or managed a Quality Management System
• Experience in Cell & Gene Therapy, Biopharma, or Medical/Diagnostic Devices
• Can work with ambiguity and able to crystallize quality plans and systems
• Fluent with Quality Management software tools for paperless doc control, lab management, data analytics, etc.
• Great at statistical analysis, requirements management, reducing processing variability (six sigma), and product characterization
• Audit preparation / ISO 13485 compliance controls / cGMP

If you meet the requirements above and would like to be considered for this position, apply on-line now for immediate consideration and to be contacted with further details.