Zeny is a QA professional with over 40 years of extensive hands-on and management experience in the pharmaceutical, medical device, IVD, biologics, cell-therapies and nutritional supplements industries. She has experience with FDA and EMA regulations, the Medical Device Directive (MDD), the Medicines Control Agency if the UK, Health Canada (HPFBI), Mexican Health Authority, the Pharmaceutical & Medical Device Agency (PMDA) and the Japanese Ministry of Health (MHLW), and applicable ISO and ICH Standards as well as compliance with the Controlled Substances Act (§ 827) enforced by the Drug Enforcement Administration (DEA).
As a consultant, Zeny has been assisting companies domestically and internationally with quality assurance and compliance programs, and in the design and implementation of quality management systems from early development to commercial stages. Her expertise includes the application of risk-based strategies, developing corrective action plans to address deficiencies, presenting GMP/QSR training, conducting GxP audits, providing PAI support and assisting clients during regulatory inspections.
Prior positions include supervisory and manager roles in Quality Assurance and Regulatory Compliance at GensiaSicor, Inc., BioRad Laboratories, Inc., J&J Ortho Diagnostics, Manufacturing Lab., and the Central Jersey Blood Bank Laboratory.
Zenaida has a BS in biology from Jersey City State College.
