Himanshu Naik
About Himanshu Naik
Himanshu Naik is a Senior Manager at Bristol Myers Squibb, specializing in Device and Combination Product Quality with extensive experience in the pharmaceutical and medical device industries.
Company
Himanshu Naik currently works at Bristol Myers Squibb as a Senior Manager Device and Combination Product Quality. His role is based in New Brunswick, New Jersey. Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines for patients. Himanshu's focus at the company involves guiding the quality management of devices and combination products, ensuring compliance with regulatory standards and improving organizational quality.
Title
Himanshu Naik holds the title of Senior Manager Device and Combination Product Quality at Bristol Myers Squibb. In this position, he is responsible for overseeing the quality assurance processes and regulatory compliance for combination products and medical devices.
Education and Expertise
Himanshu Naik obtained his B.Sc. from South Gujarat University, where he studied from 1982 to 1986. Additionally, he received a diploma from the Computer Processing Institute in 1989. He has extensive experience in the pharmaceutical, biological, and medical device industries. He is well-versed in regulatory standards such as FDA regulations, ISO 13485:2003, and EU regulations. His expertise lies in improving organizational quality, aligning business processes, and ensuring regulatory compliance.
Professional Background
Before joining Bristol Myers Squibb, Himanshu Naik worked at Bayer HealthCare as Manager QA/RA from 2011 to 2013 in Tarrytown, NY. He also served as Sr. Manager RA/QA at Excelsior Medical from 2005 to 2011 in Neptune, NJ. His prior roles include QA Investigator at Purdue Pharma, Compliance Coordinator at Wyeth Research, Chemist II at esiLederle Laboratories, Scientist III at Boehringer Ingelheim Pharmaceutical Inc, and Chemist II at SIDMAK LABORATORIES INC.
Regulatory Compliance and Quality Management
Himanshu Naik has a proven track record of ensuring compliance with regulatory standards which offers a competitive advantage to organizations. At various companies, he has guided quality management procedures, aligning technical infrastructure and business processes to achieve cost savings and enhanced organizational performance. His experience encompasses adherence to FDA, ISO 13485:2003, and EU Regulations.