Scott Goodberlet

Experience

1. VP and Head of Quality Americas Region and Device Quality

   AstraZeneca

   Sep 2018 — Present · Durham, MD

   Accountable for Quality Operations of pharmaceutical products at nine North and South American supply sites and for Device Quality Globally including Combination products and Software as a Medical Device for Small and Large molecules at AstraZeneca.

Education

• Canisius University

  Bachelor's degree, Biochemistry

  1988 — 1992

• McQuaid Jesuit High School

  H.S. diploma

  1984 — 1988

Skills

• Technology Transfer
• Public Speaking
• Quality Management
• Cgmp Practices
• Usp Expert Committee Member 2005-2010
• Operational Quality
• Gmp
• Site and Global Leadership Team
• Validation
• Consent Decree, Warning Letter and Ema Critical Remediation
• Analytical Development and Validation
• Us Fda, Imb, Ema, Iso, and Other Regulatory Inspection Management
• Pharmaceutical Industry
• Sop
• Fda
• Quality Auditing
• Chemistry
• Biopharm, Pharma, Otc, Medical Device and Primary
• Quality System
• Medical Devices
• Capa
• Compliance
• Pharma and Consumer Roles in USA, Puerto Rico, France and Ireland
• Sterile, Solid Dose, Respiratory (Mdi and Dpi), Transdermal, Liquid, Etc.
• Change Control
• Qc, Stability and R&D Lab Management
• Glp
• 21 Cfr Part 11
• Quality Head for Pharma and Consumer Sites in Ireland and USA