Irina Plotnikov
About Irina Plotnikov
Irina Plotnikov is the Associate Director of GMP/GLP Corporate Audit & Inspection at Bristol Myers Squibb, with over 20 years of experience in various pharmaceutical functions.
Current Role at Bristol Myers Squibb
Irina Plotnikov is currently serving as the Associate Director, GMP/GLP Corporate Audit & Inspection within the Global Compliance Group at Bristol Myers Squibb. Based in Summit, New Jersey, she leads multiple compliance functions, focusing on Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) audits and inspections to ensure regulatory adherence and integrity within the organization.
Professional Experience at Enzon Pharmaceuticals
Irina Plotnikov held several roles at Enzon Pharmaceuticals. She initially worked there as R&D Compliance from 2010 to 2013. After this period, she continued to engage in similar capacities, contributing valuable compliance expertise to the company's research and development operations.
Previous Positions in the Pharmaceutical Industry
Irina Plotnikov has a diverse background in the pharmaceutical industry, having worked in various supervisory roles for companies like Johnson & Johnson, Cambrex, Celgene, and Silliker Labs. Her roles ranged from Lab Supervisor at Johnson & Johnson to AD/QC Supervisor at Cambrex. She has accumulated significant experience in Analytical Chemistry, Quality Control, and Compliance over more than two decades.
Education and Advanced Expertise
Irina Plotnikov earned her Master's degree in Chemistry and Biology from Krasnoyarsk Pedagogical University, where she studied from 1982 to 1987. Her extensive educational background provides a strong foundation for her specialized roles in Quality Assurance, Compliance, and Analytical Development within the pharmaceutical industry.
Extensive Audit and Compliance Experience
Irina possesses extensive worldwide pharmaceutical auditing experience. She has conducted audits of third-party contract manufacturers, CMOs, CROs, contract analytical laboratories, raw material suppliers, clinical sites, and internal global systems. Her detailed knowledge of cGMP, GLP, ICH, USP, EP guidelines, and FDA regulations further underscores her competence in maintaining high standards of regulatory compliance.