Title: Director of Quality Assurance CDMO
Location: Greater Boston, MA area
Generous Relocation Assistance provided
Onsite Presence Required
JOB SUMMARY
The Director of Quality Assurance is responsible for managing all aspects of the Quality Assurance while developing, implementing, and maintaining an effective Quality Management System under appropriate regulations and standards. The Director of Quality Assurance is responsible and accountable for all aspects of the Quality Management System (QMS), Supplier Quality, and the Quality Operations Group (QOG). The Director will coach and support personnel in a cGMP manufacturing environment, either as the task holder or through subordinates. Has knowledge and skills across a range of Quality practices, procedures, and principles, with an astute ability to easily rank priorities based on importance and feel comfortable making decisions on quality issues. Manages and supports a variety of processes, including Document Control and Change Control processes. Responsible for material and Finished Goods Disposition and Release. Must be able to lead and work with cross-functional teams and track projects to completion. Requires experience in cGMP manufacturing environment plus demonstrated familiarity with standard quality concepts, practices, and procedures.
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