Jeff Wedeking

Jeff has over 30 years of experience in the Biopharmaceutical industry leading quality assurance teams in support of early stage development through well-established commercial products for biologics, small molecule, and gene therapy programs.  Prior to consulting, Jeff held leadership roles at both Amgen and BMS including Site Quality Head, Director External Quality, and Quality Director over Mammalian Manufacturing Operations at Amgen’s Juncos site.  Jeff has a proven track record and a broad range of experience providing support and expertise across the entire GMP Quality landscape including oversight of GMP clinical and commercial manufacturing operations, facility commissioning and qualification, batch release, quality systems development and execution, eQMS implementation, supplier quality management, GMP audits and inspections, inspection readiness prep, and regulatory submissions.  Jeff holds a B.A. in Pharmacology from University of California Santa Barbara.