About

Seasoned, energetic Quality Assurance and Regulatory Affairs professional with 20 years of experience in pharmaceuticals, medical devices, and combination devices. Extensive experience in implementing quality systems to current industry standards and regulatory expectations for pharmaceutical and medical device organizations.

Professional Skills

• Managed quality managers and quality engineering staff for new product development and commercial production for device, drug, and combination products
• Subject matter expert in managing design control and post-production requirements for medical device products following 21 CFR Part 4, 21 CFR Part 820, ISO13485, and 2017/745 EU MDR
• Subject matter expert in creating supplier quality processes utilizing a risk-based approach in the management of suppliers utilized in product development, manufacturing, automated systems, and IT
• Implemented 21 CFR Part 11, 210/211 regulations in organizations for drug-device and device-drug combination products
• Host FDA and International regulatory agency inspections

• Implemented tools and effective communication of expectations of ISO14971 in product development and manufacturing
• Managed GxP requirements and expectations in pharmaceutical and medical device organizations
• Extensive knowledge of Aseptic Lyophilization Processing for sterile injectable drugs
• Certified Six Sigma Green Belt