Pharmacovigilance Quality Assurance Manager

Role: Pharmacovigilance Quality Assurance Manager responsible for leading GxP audits and inspection support within Johnson & Johnson's Innovative Medicine division. Objectives include ensuring compliance with regulatory standards and internal policies through independent audits, assessments, and inspection readiness. Responsibilities encompass planning and conducting routine and complex audits, supporting regulatory inspections, managing CAPAs, and mentoring junior auditors. The role also involves project management and stakeholder interaction, particularly in pharmacovigilance system audits. Qualifications required include a minimum of 6 years in a GxP regulated industry, with at least 3 years in pharmacovigilance auditing, a bachelor's degree in life or related sciences, and fluency in English. Preferred skills include experience with complex pharmacovigilance audits, project management, and strong communication abilities. High-value specifics involve pharmacovigilance compliance, GxP standards, audit leadership, and international travel (~25%). The position is based in Raritan, NJ, with a flexible location across multiple countries.