Head of Quality, with a broad background in Pharmaceutical and Laboratory sciences (specializing in business development) with R&D and commercial manufacturing (sterile and non-sterile) experience with over 17 years industry practice. Overall background and specialties include GMP & GLP, which has led to strategic management of major programs such as gap analysis and transformation of Product Quality Systems (PQS), SOP transformation and optimization, QMS frameworks, and operational systems audits. She is passionate about continuous improvement activities and consistently building quality into each area of the life sciences. Advocate & Committee Member for the Tourette’s Association of America and Powershift Ambassador for Daymond John.

Accomplished Quality Professional with a broad background in pharmaceutical life sciences having R&D through commercial experience with 25+ years of practice in Quality & Manufacturing, global consulting, and business development. Experienced and well versed in GMP and have working knowledge of GCP/GLP frameworks for FDA/EU regulations and guidelines. Experienced in Deviation/CAPA Management, Change Management, SOP development, Vendor Oversight and Quality Auditing, Regulatory Inspection Readiness, QMS development and implementation, Training, CMC documentation review and product disposition. Other areas of experience include Product Complaint investigations, APR/PQR, Quality metrics compilation and reporting.

I have been working in the Pharmaceutical Industry since 2000, with experience ranging in Quality Control Microbiology, Quality Systems, and Regulatory Affairs. I have extensive knowledge of both Commercial (sterile and non-sterile) and Research & Development. I specialize in GLP, GMP, Quality Compliance, Quality Management Systems. I am enthusiastic about continuous improvement, performing gap analysis on processes, and providing/implementing solutions. I am an SME in the investigation of deviations, determining root causes, and proposing corrective and preventive actions.