Director, Central Quality Audit, Pharmacovigilance

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $142.4k - $213.6k / year

⏰ Full Time

🔴 Lead

👔 Director

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GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

💊 Pharmaceuticals

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.

📋 Description

• Own the Pharmacovigilance (PV) Audit Program: Develop, implement, and maintain the global PV audit strategy. • Manage Audit Operations: Oversee scheduling, planning, execution, reporting, and follow-up for PV audits. • Risk Identification and Communication: Identify high-risk compliance issues, escalate findings, and provide actionable recommendations to senior leadership. • Regulatory Inspection Support: Prepare for and support PV-related health authority inspections. • Metrics and Reporting: Define and track PV audit KPIs, ensuring visibility of compliance risks and trends to leadership. • System Ownership: Manage audit-related modules within the electronic Quality Management System (eQMS). • Team Leadership: Lead and develop a team of 3–5 auditors.

🎯 Requirements

• Minimum 5 years of people leadership experience, including team development and performance management. • Qualified Lead Auditor with active certification. • Master’s degree and 5+ years in pharmacovigilance or pharmaceutical industry; or Bachelor’s degree and 10+ years relevant experience. • Minimum of 5 years’ experience driving Global programs to resolve quality compliance issues (directly). • Experience with Pharmaceutical QMS requirements and regulatory requirements including but not limited to cGMP, GDP, GPvP, GCP and GLP.

🏖️ Benefits

• medical, dental, vision • paid time off • 401(k) plan with employee and company contribution opportunities • life insurance • disability insurance • accident insurance • tuition reimbursement