Kevin Gamarello

About Kevin Gamarello

Accomplished Quality Assurance leader with over twenty-five years of experience, leading GMP/GDP Quality Operations and Inspection Readiness for small molecules, biologics, medical devices, and cell and gene therapies. Responsible for advancing inspection readiness, risk identification, and governance to strengthen compliance and operational excellence through collaboration with QA and business area stakeholders. Equipped with certification as an ISO 9001/13485 FDA Regulated Lead Auditor and a strong background in quality operations and risk management. Passionate about aligning organizational processes with compliance regulations to ensure effective and sustainable quality systems that support successful inspection outcomes.

Experience

1. Director, Cmc Quality Inspection Readiness

   Vertex Pharmaceuticals

   Sep 2023 — Present · Boston, MA, US

   Leads GMP/GDP Inspection Readiness (IR) function for small molecules, Biologics, Medical Devices and Cell and Gene Therapies with responsibility for the overall performance and effectiveness of the program.• Grew Inspection Readiness function from 3 associates to 9. • Accountable for advancing inspection readiness activities, risk identification, resolution and governance including providing oversight /guidance on remediation activities • Collaborates for alignment with QA (e.g. Operational QA, Audit and Inspection Management, Vendor Management) and business area stakeholders in risk identification and assessment • Monitor submission readiness activities including highlighting risks to senior management associated with submission/inspection readiness• Partners with internal/external stakeholders including Contract Manufacturing Organizations, Vertex Manufacturing Center, Technical Operations, Supply Chain and others within Quality Assurance for alignment and collaboration in integrating quality performance/monitoring and implementing best practices • Accountable for oversight of Submission Audits and the governing process to support submission timing and expectations• Continually evaluates opportunities to modify the IR team\'s approach, resource deployment and areas of focus to align with top risk reduction priorities across CMC areas, including third parties/vendors • Actively champions, models and drives for continuous improvement and excellence in execution • Implements leading practices for enabling commercial success and pipeline advancement through proactive and effective quality management.• Champions a culture of continuous learning across the team relating to CMC operational areas and technology platforms as well as the industry standards for inspection readiness and risk management • Leads and engages IR team within Quality Assurance for excellence in delivery of organizational and operational strategies and goals

Education

• Ramapo College of New Jersey

  Bachelor of Science - BS, Environmental Science

  1992 — 1997

• Stevens Institute of Technology

  Master of Science - MS, Management Information Systems and Services

  2004 — 2007

• Fairleigh Dickinson University

  Master of Business Administration - MBA, Pharmaceutical Management

  2009 — 2012

Skills

• R&D
• Trackwise
• Pharmaceutics
• Investigations
• Cross-Functional Team Leadership
• Analytical Chemistry
• Laboratory Analysis
• 21 Cfr Part 11
• Customer Focus
• Technology Transfer
• Quality Oriented
• Quality Assurance
• Quality Control
• Collaborative
• Gmp
• Supply Chain Management
• High Energy
• Gxp
• Quality Auditing
• Aseptic Processing
• Glp
• Regulatory Affairs
• Capa
• Computer System Validation
• Team-Oriented
• Software Documentation
• Gamp
• Gcp
• Biopharmaceuticals
• Team Oriented
• Highly Analytical
• Customer Relations
• Cleaning Validation
• Lims
• Dissolution
• Laboratory Automation
• Clinical Trials
• Sop
• Fda
• Quality System