Lead global pharmacovigilance audits for GE HealthCare’s Pharmaceutical Diagnostics business, applying pharmaceutical quality assurance expertise and regulatory knowledge. This Global Quality Assurance Auditor supports CQA with auditing focused on PV-related functions and GMP manufacturing sites. The work includes internal and external audit programs, trend analysis, and compliance assessment. You will monitor regulatory changes and support operating procedure, risk assessment, and change control updates. Key Responsibilities:

Plan, prepare, and execute internal and external audits Analyze audit trends and quality-related data Support regulatory inspections and customer audits Review CAPA effectiveness and Quality Event approvals Monitor regulatory changes and inform the company Requirements:

Bachelor’s degree or qualifying pharmaceutical industry experience Six or more years in the pharmaceutical industry Previous auditing experience and regulatory agency interaction Knowledge of GPvP, cGMP, and GDP Robust communication, analysis, and problem-solving skills Apply pharmaceutical auditing, PV compliance, and regulatory expertise to strengthen quality oversight across GE HealthCare’s global operations.

📌 Global Pharmacovigilance Quality Auditor (Winnipeg)
🏢 GE HealthCare (United States)
📍 Winnipeg