Internal Audit Subject Matter Expert and Lead Auditor. GxP Compliance Subject Matter Expert for the site. Director Level Nonconformance Report QA Review and Approval. Director Level CAPA QA Review and Approval. Director Level Material Review Board QA Review and Approval

Developed the technical content of Common Technical Documents (CTDs) for the Chemistry, Manufacturing and Controls (CMC) section required for initiation and maintenance of the INDs. Development of Quality Systems. QA Management of contract organizations responsible for the manufacture and testing of drug substances and drug products

Managed the execution of Global Field Actions. Divisional QA liaison for Drug and Device Field Actions. Reconfigured the Global Field Corrective Actions Quality System.

Lead contact with the FDA for all Biologics License Applications (BLAs) and Medical Device filings asscociated with BioLife Plasma Services LLC with Baxter Healthcare. Team leader for the licensing of HCV and HIV PCR plasma screening tests for the operation based in Vienna, Austria. Regulatory Affairs lead resource for the Donor Information System (DIS) 510(k) development. Change Control Board member (Regulatory Affairs) for all Biologics and Medical Devices. Developer of the DIS Medical Device Reporting (MDR) and Change Compliance Evaluation systems. Responsible for the draft/review of all Biologics/Medical Device-related submissions to the FDA.

Technical Specialist - PRISM Business Team. Authored Chemistry, Manufacturing, and Control (CMC) section for PRISM HTLV IND and BLA submissions. Managed troubleshooting/co-manufacturing with plant in Delkenheim, Germany. Technical Specialist - TDx Business Team. Lead technical resource for a team responsible for the manufacture, quality, compliance of reagents, and labeling for the Therapeutic Drug Monitoring (TDM TDx) Medical Device product line. Lead technical resource for the 510(k) submission of second generation assays. Managed the section responsible for the technical support (CMC) of the manufacture/testing of reagents for the TDx Medical Device product line. Enabled the transfer of technology to plant in Puerto RicoProduct Manager - Hepatitis Diagnostic Technical Support Led of technical support of manufacturing and testing (CMC) of reagents for anti-Hepatitis B (AUSAB) IMX, EIA and RIA. Change Control Board member for manufacturing and testing of the above