Recognized health care manufacturing industry expert, with a blend of
Technical and business education Expertise in global manufacturing, quality assurance, regulatory affairs and compliance
Technical expertise in pharmaceuticals, dietary supplements, dosage forms and APIs, medical devices and diagnostic products and cosmetics Strong written and verbal communication skills Commitment to industry demonstrated through organizational and government regulatory contributions Numerous presentations, publications and patents
Key Success Factors
Technical expertise as well as the necessary access to the FDA to implement successful audits and inspections, through full compliance, and approvals for product application regulatory approvals, ie, ANDAs/NDAs, DMFs Lead global manufacturing and corporate initiatives. Provide uniform operations in plants for product registrations worldwide, thus ensuring higher levels of compliance and reduced costs. Organizing teams and establishing and implementing systems which produce results, as evidenced by successful company integrations from merger/acquisition activities. Management of multinational, multiplant operations to achieve corporate goals and global regulatory compliance – manufacturing, quality assurance and regulatory affairs and compliance. Achieve worldwide product registrations and GMP compliance. Integrate the manufacturing and quality operations in a multinational organization into uniform and consistent quality standards and systems. Participation in a growing organization, to utilize my technical and business background and expertise toward developing the company’s business and ability to supply quality products.