Lechinesa Harry

Background

About Lechinesa Harry

I am a Quality Assurance leader with a diverse background within the quality assurance industry spanning 15 years. I’m experienced in maintaining, managing, and implementing quality systems within contract research organizations (CROs), contract laboratories as well as biotechnology, dietary supplement, medical device, and pharmaceutical companies. My expertise lies in GxPs and end-to-end processes associated with non-clinical, pre-clinical, and clinical trials, product development, regulatory submissions, method validations, process validations, client and regulatory audit preparedness, project management, vendor qualification, vendor oversight, technology transfers, risk management, clinical and commercial manufacturing, and post-market surveillance.I have extensive knowledge of: 21 CFR Parts 11, 50, 54, 58, 56, 210, 211, 312, 314, and 820ICH Guidelines E2 A-F, E6 (R2), Q2 (R2), Q1A (R2) and Q14ISO Standards 9001, 14971, and 13482EU Directives, NLCP, CAP, CLIA and WHO GuidelinesI began my career in manufacturing a stem cell-based drug and quickly discovered my passion for quality assurance while assisting with investigations and batch record reviews. I spent the remainder of my early career working in quality assurance, primarily within CROs and later moved into leadership roles and managing corporate quality strategies within multiple disciplines. My broad experience has equipped me with the ability to identify gaps in processes, understand touch points across cross-functional groups, and align organizational goals with client and patient needs. I thrive on implementing risk-based approaches, streamlining operations, and ensuring the integrity of bioanalytical data, clinical trials, and therapeutic products.