Leigh Toole
Site Quality Head @Kindeva Drug Delivery
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WORK HISTORY
Site Quality Head @Kindeva Drug Delivery
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
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.
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