SUMMARY An accomplished, charismatic and energetic leader with over 20 years progressive experience in multiple regulated industries. Expertise in Regulatory Compliance, Supplier Quality, Quality Assurance, Quality Control, domestic US cGMP (QSR) and international Quality Management System (QMS) implementation and/or improvement. Experience with US and European Regulatory Agencies and an expert facilitator for FDA and other Third Party audits. Additional competency in non-quality compliance roles such as Conflict Minerals and Anti-Modern Slavery.

Highlights:

• New Jersey
• Management
• people management
• Facilitator
• Internal audit
• ISO
• FDA
• LMS
• MDR
• Supplier Quality
• Quality Assurance
• QMS
• Validation
• Quality Agreement
• CAPA
• QSR
• cGMP