Pharmacovigilance QA Auditor Specialist

Role: Pharmacovigilance QA Auditor Specialist responsible for overseeing PV internal and external audits to ensure compliance within Johnson & Johnson's Innovative Medicine division. Main objectives include leading audit planning, conducting assessments of data, facilities, and processes in GxP and non-regulated areas, supporting regulatory inspections, and providing compliance consultation to business partners. Responsibilities encompass project participation, audit reporting, and assisting in training material development. Requirements: Bachelor's degree in life, natural, or computer science; minimum 4 years' PV experience; strong project management, data analysis, communication, and collaboration skills; proficiency with Microsoft Office. Preferred: broader audit landscape understanding and varied audit experience. Travel: approximately 25% domestically and internationally. High-Value: PV compliance, GxP auditing, regulatory inspections, cross-functional collaboration, focus on quality assurance in pharmacovigilance processes, supporting global audit and compliance initiatives.