Director, QA R&D - PV Audits

The Director of Pharmacovigilance Auditing is responsible for implementing a comprehensive audit program and leading a high-performing team of audit staff to assure AbbVie’s Pharmacovigilance (PV) system has proper quality, integrity and controls via strategic audit oversight. Audit management includes auditing, people leadership/development and compliance reporting where required. This role will ensure that R&D remains in compliance with the corporate policies and applicable worldwide regulations.

The role includes strategic leadership of Audit Programs to assure compliance, external audit of AbbVie and inspection readiness across the scope of our Portfolio, global footprint and the foundational connections of our complex PV System. Provide consistent and aligned consultation to R&D leadership stakeholders from multi-functional interactions with a focus on audit management, risk decisions, metric/process reporting with a data-driven, comprehensive quality perspective. Influencing the decision-making process to drive foundational quality requirements into process, issue and risk management and inclusion within process improvement initiatives.

Core competencies expected for this role: Quality management, Audit program management, Strategic and dynamic team leadership, Critical communication skills, Functional expertise and Analytical aptitude for the subject matter.