Amy Ruscavage

About Amy Ruscavage

Strategic and results driven leader with over 27 years of GxP Quality and Compliance experience in medical devices, small molecules, biologics and combination products; from development through commercialization. Proven track record in successfully managing multiple large scale/high profile projects/programs, specifically; building, remediating, and continuous process improvement of GxP Quality Management Systems for both start up and large pharmaceutical companies. Passion for working in fast paced environments with changing priorities,\"wearing many hats\" and being “hands on” to achieve company objectives.

Experience

1. Vice President, Quality

   Treeline

   Oct 2023 — Present

   Hands on Quality leader responsible for the development and implementation of a phase appropriate Sponsor Quality Management System,including process/procedure development, qualification of GxP third parties, and IT infrastructure• Responsible for the execution and oversight of daily Quality activities in support of preclinical, clinical and manufacturing operations

Education

• Commonwealth University-Bloomsburg

  B.S, Biology

• Temple University

  Master's degree, Quality Assurance/Regulatory Affairs

Skills

• Biopharmaceuticals
• Quality Assurance
• Medical Devices
• Capa
• V&V
• Verification and Validation (V&V)
• Biotechnology
• Change Control
• Pharmaceutical Industry
• Sop
• Fda
• Technology Transfer
• Corrective and Preventive Action (Capa)
• U.s. Food and Drug Administration (Fda)
• Six Sigma
• Pharmaceutics
• Validation
• Gmp
• Regulatory Affairs
• Auditing
• U.s. Title 21 Cfr Part 11 Regulation
• 21 Cfr Part 11