Responsibilities Leads preparedness for regulatory inspections ensuring compliance with global standards Conducts mock audits and coaches site leadership for successful audit outcomes Develops audit and inspection readiness plans Collaborates with AbbVie teams for compliance and quality deliverables Provides guidance on quality concerns ensuring new product launches meet requirements Requirements Bachelor’s Degree in relevant Life Science or other technical area required Graduate degree desired 10+ years of experience in Quality Assurance, Regulatory, Operations, or Technical Support in a pharmaceutical or medical device setting required Experience working in a regulatory agency preferred; direct interaction with regulatory inspectors required 6+ years of direct Plant leadership in a pharmaceutical setting preferred Experience working with third party external manufacturers preferred Comprehensive understanding of biological and/or pharmaceutical technologies (sterile, biological, devices, etc.) Strong analytical problem-solving skills #J-18808-Ljbffr
