Brian Kelly is a seasoned professional with expertise in Quality Processes and Regulatory Affairs for the Life Sciences industry. Holding an Associate of Science degree in Business Administration and Management from Ivy Tech Community College, and having studied Business Administration and Management, General at Purdue University, Kelly brings a wealth of experience to the table.

As a Senior Technical Recruiter and Business Development Executive at GxPartners, Kelly is responsible for managing quality services ranging from designing, implementing, and managing Quality Systems to ensuring regulatory compliance, risk management and product validation with global industry standards such as 21 CFR 210, 211, 820, ICH-Q series, ISO 13485 and 14971.

With an extensive background in all quality functions, Kelly has experience improving the quality within the supply chain, performing failure investigations, implementing CAPAs, and conducting quality system remediation or implementation. With his expertise in Regulatory Affairs, Kelly has helped numerous clients with pre-market submissions for 510k/PMA/NDA/ANDA/BLA, and post-market surveillance activities including Recall Support.

Kelly has also been involved with Risk-based Validation processes, helping Life Sciences manufacturers provide objective evidence of their products' reliability with every batch or lot produced. Some of the validation services he offers include Commissioning and Qualification of Facilities, Utilities and Equipment, Process Validation, Software and Computer System Validation, and Cleaning Validation.

Prior to joining GxPartners, Kelly has held various leadership roles such as Business Development Manager at Treximo and Networks Connect LLC, as well as Client Services Executive/Account Manager for Theoris Services. He has also been a Recruiter at Adecco Staffing, USA and a Regional Training Manager at Healthcare Services Group, Inc.

Overall, Kelly is a highly skilled and experienced professional with expertise in Quality Systems, Regulatory Affairs, and Product Validation, making him a valuable asset for any Life Sciences company looking to improve their product quality and regulatory compliance.