The Executive Vice President (EVP) of Quality is a senior leadership role responsible for developing, implementing, and overseeing quality assurance (QA), quality control (QC), regulatory compliance, and operational excellence programs in a dietary supplement manufacturing environment. I ensure all products meet industry regulations, company standards, and customer expectations while driving a culture of quality and continuous improvement throughout the organization. Integration of high level customers into our quality program through quality agreements

I have worked with start ups to the 300M+ year organization. DS Regulatory Consulting offers a variety of regulated products consulting, submission, and auditing services including:-Assistance on GMP Part 111, 211, 820 Compliance and Complete Set Up, Design, Implementation, and Gap Analysis of Quality Systems-Conducting GMP audits and FDA audit assistance-Labeling Review and Marketing Compliance-Preparing NDI submissions to FDA-Evaluation of Structure Function Claims and Preparation of Notifications to FDA-Providing Guidance on Importation and Exportation of Dietary Supplements -Obtaining FDA Export Licenses-Recall Management and Project Management-Supplier Qualification Programs-Laboratory Operations Assistance-Employee Training Programs-Supplier Quality Agreement Development

Part-time contract Director of Compliance working with management team to navigate the regulatory hurtles of Compassionate use exportation of Health Products including Non-approved investigational drugs, marketed approved drugs, and dietary supplements meeting the needs of specialized patients who otherwise would not have access to treatments. Managing all aspects of EC 2013/C 343/01 Good Distribution Practices of Medicinal Products for Human Use throughout the organization and external customers requirements.

Dietary Supplement contract manufacturer for health food industry. Worked with staff to update and implement Quality Systems to become Part 111 complaint with cGMPs. Established in house testing laboratory and supplier qualification program. Managed customer relations for larger accounts such as GNC and Vitamin Shoppe

Preparation activities for sBLA for the Atlanta IMF facility, Biological Deviation Reports, Change Control, FDA audit preparation activities. Organize, write, review, and prepare regulatory submission for all BLA activities, Monitors and assesses change control activities across a broad spectrum of manufacturing activities. Represents regulatory in cross functional teams, projects, and GxP-releated problem resolution.

General RA duties in preparation for CE Mark

Sales and marketing for Reguatory Publishing group. We can provide all your electronic publishing needs from clinical to post-market submissions.

Working on NDA and sNDA for new and marketed drug products. Preparing annual reports and researching yearly change controls. Regulatory Intelligence. Various types of US regulatory submissions.

UGA intern in Regulatory Affairs focusing on Regulatory Strategy, NDA/sNDA submissions (eCTD), and Change Control Processes. I worked inside the project group and attended meetings with QA, Clinical, and contract manufacturers to move a new product to market.

• Helped prepare QMS documentation for upcoming FDA audit under the guidance of the Director of Quality Systems (Class 2 devices)• Developed Master Label binder for use by employees• Prepared and audited device master file for oral dispensers• Review, audited, and updated device master records for all products• Updated design history indexes for all products• Designed study for validation of shipping methods

• Directed all regulatory and quality assurance activities for a Class 3 medical device-Intraocular Lens manufacturing company• Successfully moved location of facility from Kennesaw to Cartersville in preparation for FDA approval decommission/commissioning of equipment, full validation various systems, rework of process flow charts, reviewed/updated/implemented SOPs• Passed ECM (governing body) audit to obtain CE mark with no major violations or corrective actions of July 2008• Supervised document control specialist and conducted ISO 13485, SOP, and work instruction training for staff• Implemented company safety program to comply with OSHA standards and conducted safety training seminars• Completed various country registrations in both Hague and Non-Hague Convention countries through out Europe, Africa, Middle East, Southeast Asia• Obtained EAR classification of products and State Dept OFAC license for direct shipment of goods to the country of Iran under Ag/Med Program • Began work on technical file (device master file) for new product development as well as updating current technical files• Conducted audits of critical vendors as needed• Directed yearly Management Meeting in September 2008• Monitored adverse events and conducted investigation for root cause determination and CAPA assessments • Helped to develop initial clinical trial protocol on the Precision Lens IOL

Lead in-vivo scientist for all pre-clinical compounds at Atlanta R&D facility.

Medical Research in the Department of Urology under Dr. Anthony Schaeffer MD.and Dr. David Klumpp PhD. We studied urinary infection by e.coli bacteria and IC, an inflammatory bladder disease.