Paul Stanley

About Paul Stanley

Drive Quality Maturity through Smart, Efficient & Enabling Quality Management. Driven leader with broad Quality Control and Quality Assurance experience within the pharmaceutical and medical device industries. Hands-on, visible, collaborative leader who applies risk-based strategies to produce sustainable, phase-appropriate quality systems and organizational design to ensure patient access to safe and efficacious product. Enthusiastic, agile, and resilient leader who achieves results with integrity. Passion for cultivating and enabling employee engagement and quality culture.QMS Design and Implementation | Organizational Design | Sterility Assurance | Clean Area Control | Vendor Management | Internal /External Audit | Deviation Investigations | Complaint Management | Change Management | Training | Inspection Readiness | Employee E••••••••@gmail.com

Experience

1. Vice President, Head of Quality

   Astria Therapeutics, Inc

   Dec 2021 — Present · Boston, MA, US

Education

• University of Massachusetts Amherst

  BS, Microbiology

• Boston College Carroll School of Management

  MBA, Organizational Behavior

Skills

• Capa
• Quality Assurance
• Corrective and Preventive Action (Capa)
• Computer System Validation
• U.s. Title 21 Cfr Part 11 Regulation
• Change Control
• Cross-Functional Team Leadership
• Sop
• Fda
• 21 Cfr Part 11
• Biotechnology
• Biopharmaceuticals
• Aseptic Processing
• Microbiology
• Technology Transfer
• Standard Operating Procedure (Sop)
• Quality System
• V&V
• Validation
• U.s. Food and Drug Administration (Fda)
• Quality Control
• Gmp