“Certified pharmaceutical GMP Auditor, Certified Lean Six Sigma Black Belt”.

Qualified Lead Auditor for ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 14298, ISO 13485 Management systems

Proven leader over two decades of experience in the drug substance and drug product pharmaceutical industries. Expertise including, but not limited to the following: creation, implementation and maintenance of the Quality System processes, in compliance FDA 21 CFR, Part 210, 211, ICH and ISO 9001-2015. Manage all aspects of regulatory compliance. Correspond with FDA and EU notified bodies. Prepare and maintain international product registrations. Filling facility registration and Product Listings. Maintenance of regulatory files, consistent with state, federal and international regulatory requirements. Provide knowledge and support to the company to enable company to operate within regulatory guidelines.

Core competencies

Develop regulatory strategies for U.S, Europe, China, Brazil, and Mexican and ROW markets. Host FDA and regulatory agencies audits. Complete annual registrations. Review and interpret regulatory rules as they relate to company products and processes. Conduct ongoing company-wide training on FDA, EDQM and ISO requirements. Assess need for regulatory registrations and act accordingly. Document Control process and the efficient control of all documentation required by regulatory agencies. Define needed quality metrics and coordinate data collection from various functions. Perform Quality Management Reviews and advise management of any product or process related issues and make recommendations for improvements. Administer and manage supplier qualification activities and monitor suppliers’ performance.f