Director, Central Quality Audit, Pharmacovigilance

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👔 Director

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GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

🏥 Healthcare

💊 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, ensuring alignment with regulatory expectations (e.g., EMA, FDA, MHRA, PMDA) and industry best practices. • Manage Audit Operations: Oversee scheduling, planning, execution, reporting, and follow-up for PV audits, including internal audits and audits of service providers and affiliates. • Fully participate in the audit program; actively owning and executing 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, including back-room management and post-inspection follow-up. • 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), including support of configuration, UAT, and documentation. • Team Leadership: Lead and develop a team of 3–5 auditors, providing coaching, mentorship, and performance management. • Cross-Functional Collaboration: Partner with PV Operations, Quality, and Regulatory teams to ensure audit outcomes drive continuous improvement. • Strategic Influence: Contribute to policy development and influence PV compliance strategy across the organization.

🎯 Requirements

• Minimum 5 years of people leadership experience • 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. • Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485 • Prior Veeva and TrackWise Digital experience a plus. • Prior health authority experience a plus. • IRCA, ASQ (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt). • Extensive experience in the Medica Device and Pharmaceutical industry. • Strong oral and written communication skills in English. • Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others.

🏖️ Benefits

• Health insurance • Professional development • Competitive compensation • Career opportunities in a culture that fosters care, collaboration and support.