Violetta Akopian

About Violetta Akopian

Thank you for visiting my profile. Conversations welcome. Email: v•••••••@shaw.ca My expertise is in drug development, manufacturing, quality and supply operations from the pre-clinical stage through commercialization, leading multi-cultural cross-functional global teams across the US, Canada, Europe, and Japan. My strengths are building Quality Systems, which become robust foundations for pre-clinical and clinical studies, and Chemistry Manufacturing and Controls for Drug Substance and Drug Product. For more than 20 years I have been using my knowledge of drug development and technology transfer to help advance drugs through clinical development to commercialization for oncological diseases, fibrosis, hepatitis C, ophthalmic and genetic disorders for many companies and partners. What sets me apart from other quality professionals is my ability to blend scientific principles with knowledge of regulatory requirements to set up quality standards appropriate for a product’s life cycle, which results in compliant and time and cost efficient processes. Having been on either side of the drug development business – both in company and contract organization - has enabled me to unite the resources and technologies of both teams to achieve quality and timeline objectives in the most efficient way. I have a stellar reputation for building seamless and powerful teams capable of resolving challenges and suggesting out-of-the-box solutions. I offer outstanding program and budget management skills. I am looking to work in a fast-paced and challenging environment to contribute to many business successes. QUALITY Quality Assurance Compliance Quality Metrics Change Management Supplier Management Document Control Inspections PHARMACEUTICAL DEVELOPMENT Formulation Development Process Development Scale Up Analytical Development and Quality Control Raw Materials Management Drug Substance and Drug Product Manufacturing Technology Transfer REGULATORY CMC IND/NDA CTA Orphan Drug Designation LEADERSHIP Hands-on Leader Cross-functional Teams Project Management Partnership

Experience

1. Vice President Quality Assurance

   Viracta Therapeutics, Inc

   Aug 2021 — Present · Cardiff-by-the-Sea, CA, US

Education

• Saint Petersburg State University

  Master of Science - MS, Chemistry

• Saint Petersburg State University

  Doctor of Philosophy - PhD, Biology