Leigh Toole

About Leigh Toole

A results oriented quality assurance professional with proven success in developing, implementing, managing and improving quality systems to ensure regulatory, corporate, and internal compliance. An ethical, meticulous, dedicated, team player. Relentless in preventing and solving problems. Subject matter expertise in medical device, drug, and combination product regulations. Demonstrated proficiency in the entire product life cycle which includes research and development, manufacturing commercial product, and post market surveillance activities. Continuously applies lean thinking strategies to reduce cost of quality while maintaining quality compliance. While serving as the management representative, hosted and demonstrated compliance of the QMS during 3 successful PAI inspections at three different sites. Hosted several additional routine medical device and drug handling inspections in the past 25 years without ever receiving a 483 from the FDA.

Experience

1. Site Quality Head

   Kindeva Drug Delivery

   Sep 2024 — Present · Northridge, CA, US

   Responsible for QA and QC for inhalation drug delivery and transdermal drug delivery combination products

Education

• Arizona State University

  B.S., Biology

Skills

• Design Control
• Capa
• Fda
• Cross-Functional Team Leadership
• Design of Experiments
• Iso 13485
• Complaint Handling
• Change Control
• Medical Devices
• Combination Products
• 21 Cfr Part 11
• Iso 14971
• Cultural Change
• New Product Introduction
• Fda Pai Preparation
• 21 Cfr Part 820 (Qsr)
• Drug Delivery Systems
• Performing Quality System Audits
• Quality System Design and Compliance
• Root Cause Analysis and Issue Resolution
• Hosting Quality System Audits and Inspections
• Primary Container Closure Systems
• Sustaining Manufacturing
• Lean Manufacturing
• Quality System