• Currently developed the US Customer Information (CIQ) auditing program to ensure the US Affiliate promotional material and customer information system met regulatory expectations. In addition worked in collaboration with the Corporate Auditing Services organization bringing the Quality Systems process to their CIQ auditing program.• Serve as a Global Quality Assurance specialist auditor in the Pharmacovigilance (PhV) / Regulatory/ Product Quality (GMP and GDP)/ Third Party… Show more • Currently developed the US Customer Information (CIQ) auditing program to ensure the US Affiliate promotional material and customer information system met regulatory expectations. In addition worked in collaboration with the Corporate Auditing Services organization bringing the Quality Systems process to their CIQ auditing program.• Serve as a Global Quality Assurance specialist auditor in the Pharmacovigilance (PhV) / Regulatory/ Product Quality (GMP and GDP)/ Third Party Organizations (Service Providers/ Business Alliances/Suppliers Quality groups). Continuously improving the effectiveness of existing quality systems and processes.• Developed a seamless Global Quality and Compliance auditing process for the Pharmacovigilance, Regulatory Affairs, Product Quality (GMP and GDP) and Medical across various inter-related functions utilizing the integration of Quality Standards and GxPs in order to achieve sustainable compliance and operational excellence.• Developed a systematic approach to understand PhV / Adverse Events / Product Complaints management where I created a comprehensive program through an auditing guidance tool to train different auditing groups (GQAAC and MQA) to audit drug safety surveillance of the affiliates and third party organizations.• Through auditing, consulting and educating cross-functional teams within Global Patient Safety (US and OUS) led them to create and implement Quality Systems ensuring they are in compliance with worldwide regulatory requirements, standards and internal Lilly defined systems and processes.• Due to extensive experience in Development, Quality Control, Quality Assurance in Parenteral Production/Clinical Trials deemed a specialized auditor for the GQAAC organization. With this expertise moved to develop the auditing program for other functional groups. Show less

• Supervised the Raw Materials laboratories (WET Chemistry, Chromatography Lab, Tech Excellence Group and Compendia Group) with approximately 38 analysts. • Implemented the "Block System" and turned around the sample backlog from 4 months to 7 days and the Quality Backlog to zero deviations.• Educated the analysts and developed an aggressive GMP Improvement Plan to manage the gaps in the PMQC labs which improved the quality systems in order to be inspection-ready. The PMQC Laboratories… Show more • Supervised the Raw Materials laboratories (WET Chemistry, Chromatography Lab, Tech Excellence Group and Compendia Group) with approximately 38 analysts. • Implemented the "Block System" and turned around the sample backlog from 4 months to 7 days and the Quality Backlog to zero deviations.• Educated the analysts and developed an aggressive GMP Improvement Plan to manage the gaps in the PMQC labs which improved the quality systems in order to be inspection-ready. The PMQC Laboratories had successful inspection. • Led the Global Method Improvement Project called ICSIS (Item Codes Specific Information Sheet) to ensure all compendia methods and harmonization commitments were being followed. Show less

• Team Leader for the Pharmacological Testing, BioCell Laboratories, Micro, Endotoxin, Sterility, and Particulates laboratories managed a total of 90+ analysts focusing on reorganizing the structure of the laboratories by matching jobs with the appropriate skill sets of the analysts.• Partnered with the Biopharmaceutical Development Labs to have the Quality Control Laboratories co-develop the methods for New Chemical Entities with them. The initial project was the Hgh Cell based assay with… Show more • Team Leader for the Pharmacological Testing, BioCell Laboratories, Micro, Endotoxin, Sterility, and Particulates laboratories managed a total of 90+ analysts focusing on reorganizing the structure of the laboratories by matching jobs with the appropriate skill sets of the analysts.• Partnered with the Biopharmaceutical Development Labs to have the Quality Control Laboratories co-develop the methods for New Chemical Entities with them. The initial project was the Hgh Cell based assay with the Bio Cell Lab, the elimination of the use of cats in an Anti-Depressor assay for Capastat and the elimination of the Pyrogen assay by using the Endotoxin Kinetic assay instead.• Proactively negotiated with vendors and other Lilly Labs to identify new technology for improving laboratory methods; including the introduction of the Scan RDI, Ribo-printer, and Bioluminescence. • Developed the laboratories (Micro and Particulates) to create profiles for our products in order to implement improvements for production as well as the laboratories. This helped defend our products with any of the Regulatory Agencies.• In 2001 I was nominated for the “Chairman’s Ovation Award”, in 2002 received the WHO’S WHO in America award and in 2003 received the WHO’S WHO Award for Science and Technology. Show less

• Served as a quality consultant for the different Development CMC Project Teams. Worked closely with Clinical Trial Operations during the manufacturing process of these Parenteral New Drug Dosage Form Clinical Trial Lots ensuring all lots were manufactured in accordance to the highest quality standards. Always meeting customer demands.• Provided accurate, responsive and supportive consultation to the Clinical Trials Operations Group, and the PDI Commission regarding the quality and… Show more • Served as a quality consultant for the different Development CMC Project Teams. Worked closely with Clinical Trial Operations during the manufacturing process of these Parenteral New Drug Dosage Form Clinical Trial Lots ensuring all lots were manufactured in accordance to the highest quality standards. Always meeting customer demands.• Provided accurate, responsive and supportive consultation to the Clinical Trials Operations Group, and the PDI Commission regarding the quality and regulatory compliance for the establishment of procedures for different water systems, chill rooms, and compressed gasses as well as other building / manufacturing and / laboratory issues.. • Developed a change control process that would suit both the Development and the Clinical Trial needs.• Co-wrote a “Sterility Assurance White Paper” with different members from various areas where presentations were given to serve as guidance in the development of New Chemical Entities, including the selection of packaging. Show less

• Worked in the development of the DQS (Development Quality System) in the Biopharmaceutical Division to create SOP’s for the Development Laboratories where I received the Quality Advocate Award.• Developed, trained and improved the Physical Testing Team. Established a routine training program in order for the team to perform different physical tests in accordance to FDA, SOP and OSHA standards. • Developed the Microscopic Characterization Technique for evaluation of Insulin… Show more • Worked in the development of the DQS (Development Quality System) in the Biopharmaceutical Division to create SOP’s for the Development Laboratories where I received the Quality Advocate Award.• Developed, trained and improved the Physical Testing Team. Established a routine training program in order for the team to perform different physical tests in accordance to FDA, SOP and OSHA standards. • Developed the Microscopic Characterization Technique for evaluation of Insulin formulations. Identified the correlation between the microscopic characterization and visual test. Information was used to support the submission. • Worked as a Microscopist, where I developed the calibration and cleanliness procedures for particulate evaluation according to the USP and Japanese Pharmacopoeia. • Served as a troubleshooter by using the microscopic techniques for the identification of unknown particulates and corrected the initial problems in order to comply with the specifications of foreign countries such as Japan and France. Show less

• Supervised the Raw Materials and Finished Product laboratories and personnel. Promoted to direct the General Chemistry and the Component and Containers laboratories including the facilities. • Received the Supervisor of the Year Award in 1988.

• Trained by the Japanese to work on special projects such as the identification of unknown particles and fibers in different Parenteral antibiotics using the HIAC and the Visual Tests as described in the USP and Japanese Pharmacopoeia.• Worked with the Japanese to improve the particulate quality of the products sold in that market. After a year of developing improvements the products were within the top 10 of the market.• Worked in Method Development. Where I developed the methods for… Show more • Trained by the Japanese to work on special projects such as the identification of unknown particles and fibers in different Parenteral antibiotics using the HIAC and the Visual Tests as described in the USP and Japanese Pharmacopoeia.• Worked with the Japanese to improve the particulate quality of the products sold in that market. After a year of developing improvements the products were within the top 10 of the market.• Worked in Method Development. Where I developed the methods for the dissolution of tablets and capsules using the USP specifications. Show less