Michelle Allen
About Michelle Allen
Michelle Allen is the Associate Director of Global Quality Systems and Regulatory Compliance at Bristol-Myers Squibb, and a consultant at Map Consulting and Ember Connex.
Associate Director, Global Quality Systems and Regulatory Compliance
Michelle Allen is currently serving as the Associate Director of Global Quality Systems and Regulatory Compliance at Bristol-Myers Squibb in New Jersey, United States. In this role, she focuses on overseeing quality system design and ensuring regulatory compliance within the pharmaceutical sector. Her work emphasizes robust quality systems that align with both industry standards and regulatory requirements, ensuring ongoing improvements and adherence to compliance practices.
Consultant Roles at Map Consulting and Ember Connex
Michelle Allen extends her expertise through consulting positions at Map Consulting and Ember Connex. Her role involves providing professional advice and support on quality systems and regulatory compliance to a broader range of clients. Through these roles, she leverages her extensive background in the pharmaceutical industry to help companies improve their quality management systems and ensure regulatory adherence.
Previous Roles at Bristol-Myers Squibb
Michelle Allen has a long-standing history with Bristol-Myers Squibb, having held various influential positions. She served as the Global Quality Systems Manager, External Manufacturing, from 2013 to 2014 and as the Global API Compliance Manager from 2005 to 2012. Additionally, she was the QA Manager from 2001 to 2005. Across these roles, she consistently contributed to the company's compliance and quality assurance initiatives, strengthening its capacity for regulatory adherence and operational excellence.
Educational Background
Michelle Allen has an extensive educational background. She achieved her Master of Science degree from 2004 to 2006 and studied Chemistry at University College Dublin from 1989 to 1994. She also studied at UCD Innovation Academy in 2019. Her education has provided a solid foundation for her career in quality systems and regulatory compliance, particularly in the pharmaceutical industry.
Specialization in Quality System Design
Michelle Allen specializes in quality system design, utilizing Lean Manufacturing tools to optimize processes. Her expertise involves the evaluation and design of systems to support regulatory compliance, specifically in the pharmaceutical sector. Since August 2018, she has been providing quality systems and operation support to pharmaceutical companies, focusing on continuous improvement and ensuring regulatory standards are met.