EVP Clients & Regulatory Relations, Compliance Group
A Versatile global Quality / IT executive with over 25+ years of quality and compliance, experience in highly regulated life science industries (Medical Device, Bio-tech, Pharmaceutical and Tobacco). Deep understanding in the Manufacturing processes, Equipment validation and Lab Information Systems. Extensive background in Quality Management Systems, regulatory inspections and internal audits. Member of an FDA/Industry CSV Consortium, focusing on developing risk-based recommendation to reduce time and cost in validating software.