Results driven, process-oriented accomplished professional with over 15 years of senior leadership experience in Quality Management, Regulatory Compliance, Product/Process Development, and Project Management in U.S. and global markets serving the biotechnology, pharmaceutical, chemicals, fine chemicals and healthcare industries. Possess strong strategic and tactical background in manufacturing and production environments, holding full P&L responsibility for multimillion-dollar operations; key product development and launch initiatives and organizational transitions- mergers and acquisitions. Expert in recognized compliance standards – cGMP, ISO 9000 series and USP Verified.
Specialties: Customer & Regulatory liaison,; cGMP, ISO standards; Worldwide Regulatory Compliance; Budget Planning and Goverance; Facility/Site Management; Total Quality Management; Continuous Process Improvement