Berkshire Sterile Manufacturing (BSM) in Lee Massachusetts announces the promotion of Debbie Smith to Vice President of Quality Assurance, where she will provide executive leadership to the management of all quality oversight activities and development and maintenance of BSM’s Quality Systems.  Debbie has over fourteen years of extensive quality experience in the pharmaceutical and Biotechnology industries, with a focus on aseptic commercial production. BSM, a provider of sterile drug filling, is a fully compliant cGMP facility which uses isolators for filling to ensure the highest sterility assurance for their clients’ programs. The position of Vice President of Quality Assurance is vital to accomplishing this mission. Debbie Smith oversees the department that manages compliance program, document control, disposition of production lots, training and the auditing program. As well as collaboration with clients   on quality compliance and auditing.

“This a well-deserved promotion, Debbie has demonstrated an ability to think strategically and develop the quality system at BSM to meet GMP and EU standards for the variety of products that BSM manufactures.” said Shawn Kinney, CEO.

Before joining the BSM team, Debbie spent over twelve years working at Pfizer, Inc., holding various quality positions. Debbie is a Certified Quality Auditor (CQA) by the American Society for Quality (ASQ). While at Pfizer Debbie served as a Safety Representative and Safety Auditor in support of EHS program and OSHA. Debbie earned her Bachelor’s in Computing & Management from Herbert H. Lehman College.  She has won numerous awards, including ‘Mission’ awards for greatly improving the quality systems at Pfizer and the ‘Above and Beyond’ award for Global Environmental Monitoring Project, among others. Debbie is committed to developing a company-wide culture of quality excellence.