Tammy Lesko

About Tammy Lesko

Over the past 30+years I have focused on regulatory compliance and quality assurance in…

Experience

1. Senior Director, Quality

   RTI International

   Oct 2021 — Present

   Serve as a quality point of contact for FDA, EMA and clients, including hosting audits-Perform both internal and external audits domestically and internationally, which includes investigator site visits, outcomes research tools and data sources, process audits, and subcontractor qualifications-Perform proposal reviews for inclusion of Quality Assurance budget and text-Serve as a primary point of contact for all quality and compliance FDA liaison activities-Serve as a regulatory and quality resource for project teams-Assure that the quality and regulatory obligations of the sponsor contract are met in a cost effective and timely manner-Oversee the internal RTI-HS Quality Management System and processes, including SOPs and training records -Identify, train, and manage global staff including strategic quality consultation to the appropriate QA auditors, controlled document specialist, knowledge management-Coordinate with validation experts around hosted and on-site validated systems-Manage the qualification of all external vendors to ensure compliance with applicable regulations and standards.

Education

• Montclair State University

  BS, Biology and Chemistry

  1990 — 1993

• University of Maine at Presque Isle

  Biology/Biological Sciences, General

  1989 — 1990

Skills

• Ind
• Biopharmaceuticals
• Quality Assurance
• Pharmaceutics
• Quality Control
• Infectious Diseases
• Technology Transfer
• Gxp
• Aseptic Processing
• Drug Development
• Quality Auditing
• Internal Audit
• Ich Guidelines
• Auditing
• Fda Gmp
• Regulatory Affairs
• Protocol
• Vaccines
• Sop Development
• Clinical Operations
• Quality Management
• Gcp
• Ich-Gcp
• Fda
• Clinical Trials
• Clinical Research
• CRO
• Quality System
• Compliance
• Irb
• 21 Cfr Part 11
• V&V
• Ctms