Vice President of Quality Assurance
Debbie Smith joined Berkshire Sterile Manufacturing (BSM) in August of 2017 as Sr. Director of Quality Assurance with responsibilities for quality assurance at BSM. Debbie was promoted to Vice President of QA at BSM in July of 2018. At BSM, Debbie oversees a team of Quality Assurance, Document Control, Batch review, release and Supplier Approval aspects of QA.
Debbie Smith leads the Quality Department at Berkshire Sterile Manufacturing to ensure product quality and reliability to meet or exceed customer expectations. Debbie has over fourteen years of extensive quality experience in the pharmaceutical and Biotechnology industries with a focus on aseptic commercial production.
Prior to joining BSM, Debbie held various positions for 14 years supporting the aseptic manufacturing of commercial product at Pfizer, Inc. Throughout her career at Pfizer, Debbie managed the Quality Assurance department responsible for the disposition of incoming materials and vaccine final product. Debbie has supported the Microbiology and Analytical laboratories to ensure compliance with GLP, as well as Operations with the startup projects for the vial line and the tandem fill of the syringe line.
Debbie has a BS degree in Business and Computing from Herbert H. Lehman College.