Experienced executive with 25+ years of expertise in Quality Assurance and Quality Control directing licensed commercial and clinical products. Several years of expertise in managing CMOs, Product Development (Phase I clinical to Product Licensure), Technology Transfer, Discrepancy Management, Validation, Risk Management, QA CMC, Change Control, API Releases, QC Assay Development, and Assay Validation for international in multi-billion dollar corporations. Establish QA systems and practices as vital part of product life cycle management processes. Administer budgets topping $5M, driving 6-figure cost savings per year. Manage external regulatory inspections by world-wide agencies, craft r...
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