Randy Weeks
About Randy Weeks
Randy Weeks is the Associate Director of Quality Compliance at Bristol Myers Squibb in Devens, Massachusetts, with extensive experience in quality management and biopharmaceutical manufacturing.
Title
Randy Weeks holds the position of Associate Director, Quality Compliance at Bristol Myers Squibb in Devens, Massachusetts.
Current Role at Bristol Myers Squibb
In his role at Bristol Myers Squibb, Randy Weeks manages the audit program and administers quality management of change control. He also oversees the approval of commissioning, qualification, validation documents, and CAPA systems. Additionally, he provides QA approval on batch records, protocols, and reports related to the transfers of analytical methods and production records for contract manufacturing and testing operations, and manages the disposition of clinical lots at contract manufacturers.
Previous Experience at Medarex
From 2007 to 2010, Randy Weeks served as GMP/GCP QA Manager at Medarex. During his tenure, he was responsible for overseeing Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) quality auditing.
Previous Experience at Baxter Healthcare
Between 2001 and 2007, Randy Weeks worked at Baxter Healthcare as QA Manager for Contract/Supplier Quality. He spent six years ensuring the quality compliance of suppliers and contract manufacturers.
Previous Experience at Knoll/Abbott
Randy Weeks worked at Knoll/Abbott from 1997 to 2001 as Quality Manager Microbiology. During this period, he managed microbiology quality processes and ensured compliance with industry standards.
Educational Background
Randy Weeks holds an MBA in Business from Centenary College, a BS in Microbiology from Northwestern State University, and an MT (ASCP) from Schumpert School of Medical Technology.
Expertise in Quality Compliance
Randy Weeks has extensive expertise in clinical and commercial aseptic biopharmaceutical manufacturing. His skills include GMP, GLP, and GCP quality auditing, critical to ensuring compliance and quality in pharmaceutical production.