Paula Markos
Director II, RDQA Inspection Management
Abbvie
Bio:
I am an engineer and Quality professional with over 20 years’ experience in the pharmaceutical, medical device and combination product businesses, including over 11 years managing inspection programs to support product approval and routine health authority inspections globally. My team has oversight for the development and maintenance of unique processes for inspection preparation, logistics, and robust and timely response development for all agency findings across GCP/Pharmacovigilance/GLP and acquisitions and collaborative programs. We continuously monitoring the latest regulatory intelligence and adjust processes for the ever-changing global regulatory inspection landscape.