Paula Markos

Director II, RDQA Inspection Management
AbbVie
 

Quality professional with over 20 years’ experience with pharmaceutical, medical devices and combination products, including over 10 years managing inspection programs to support health authority inspections globally.  Currently lead the global AbbVie R&D team that administers regulatory inspections worldwide, including oversight of the development and maintenance of unique processes for inspection preparation, logistics, and robust and timely response development for all sponsor findings, for both product approval and routine GCP/Pharmacovigilance inspections.  Continuously monitoring the latest regulatory intelligence and adjusting processes for the ever-changing global regulatory inspection landscape.