Vice President, Quality
CymaBay Therapeutics. Inc
Kamal Sigel is currently a Vice President, Quality at CymaBay Therapeutics. Inc. overseeing the overall quality of organization supporting the clinical programs. She has more than 25+ global experience in Quality Systems, Lot Disposition, CDMO Oversight, Compliance Audits (GCP, GMP, PDMA, PAI, Post-Marketing), Quality Control, Validation, Inspection Readiness and CMC Submissions (FDA, HPRA, PDMA, and Health Canada). She has a Master’s in Biology and Bachelor’ in Clinical Sciences. In addition, she is a qualified witness and a certified quality auditor.
Kamal is leading the GXP work at CymaBay and driving the design and implementation of the Inspection Readiness Program at CymaBay which focuses on embedding the mindset of inspection readiness (IR) into the day-to day activities by enabling a risk-based, effective, and effortless approach to be inspection ready at all times.
Purpose Driven Inspection Preparedness: People, Process and Technology — Critical Components to Success