Director, Central Quality Audit
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Job Description
Director of Central Quality Audit at GE HealthCare ensuring compliance with external standards and managing PV audits. Leading a team to drive continuous improvement in quality practices across the organization.
Responsibilities:
- 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
- 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, 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
- Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485
Benefits:
- medical, dental, vision
- paid time off
- 401(k) plan with employee and company contribution opportunities
- life insurance
- disability insurance
- accident insurance
- tuition reimbursement
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