I’m a Principal in KPMG LLP’s Operations practice and lead our Quality and Regulatory services for the life sciences industry. I’m an experienced life sciences professional specializing in Quality and Regulatory functions of pharmaceuticals and medical devices. I advise clients from strategy through execution in current good manufacturing practices (“cGMPs”) and quality systems, regulatory pathways, commercialization, and post-market surveillance. I assist companies in implementing effective quality management systems for product quality and regulatory compliance, including the implementation of complaint handling and medical device reporting solutions.In commercialization, I provide strategic guidance on regulatory pathways and market approval requirements for pharmaceuticals and medical devices, leveraging my knowledge of US and EU regulatory frameworks.With expertise in digital health solutions, I help organizations utilize technology advancements, including artificial intelligence and machine learning, to improve patient care and optimize processes while adhering to the regulatory pathways for digital health solutions.For the past 5+ years, we’ve been at the forefront of the EU MDR transition programs for several of our medical device clients. I’ve helped companies through every phase of their transition from EU MDD to EU MDR.I assisted several pharmaceutical manufacturers and wholesale distributors in designing, developing, and implementing product serialization solutions to comply with the Drug Supply Chain Security Act (DSCSA).Additionally, I assist clients in quality issue remediation and addressing inspectional observations, guiding organizations in planning, and executing effective remediation strategies for compliance issues.KPMG LLP, the audit, tax and advisory firm, is the U.S. member firm of KPMG International Cooperative ("KPMG International"). Thoughts expressed here are my own.

Led several large business transformation programs within the Life Sciences industry by effectively deploying solutions that streamline operations, increase revenue and decrease costs in the area of Order to Cash, Procure to Pay, and Supply Chain Management. Experienced in the life sciences industry specific processes around Drug Discovery, Clinical Trials, ePedigree, Health Care Compliance and Health Information Management Systems. Led, managed and participated in various engagements involving IT Strategy, organizational alignment, Enterprise Architecture, Information Management, Large-scale application development and Program Management.Demonstrated experience in all aspects of the consulting business including business development, client delivery, solution incubation, strategic alliance development, practice management, client relationship management and building high-performance teams.

Worked as a solution architect for the portfolio of Operational Support Systems (OSS) and Business Support Systems (BSS). Worked as solution architect for the Vitria Businessware based DSL provisioning application Worked as lead architect for Enterprise Application Integration (EAI) and Enterprise Data Warehouse (EDW) projects. Responsible for designing the overall data warehouse architecture, ETL strategies based on NCR Teradata and its real time data feed integration.Developed Enterprise Application Integration (EAI) framework using Vitria BusinessWare.