Revance Therapeutics, Inc.
The incumbent will be a part of the Validation Department and will perform and/or direct computer system validation projects in compliance with cGMP, 21 CFR Part 11 and Annex 11. Validation projects may include control or computer...
Ultragenyx Pharmaceutical Inc.
Why Join Us?
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in...
Manages activities related to products and their processes. Working knowledge of Packaging equipment, solid oral dose manufacturing equipment and supporting systems (ie: USP Water System). Writes protocols for process and service...
SUMMARY OF ESSENTIAL FUNCTIONS:
The Director, Quality Assurance has oversight and leadership of Quality Assurance programs to meet phase-appropriate compliance, validation, and CLIA, CAP, NY and GxP quality assurance requirements.