Director, Central Quality Audit
GE HealthCare
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇳🇴 Norway
Visit company websiteSalary
💰 $139,200 - $208,800 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
PharmacovigilanceAudit Program DevelopmentRisk IdentificationMetrics and ReportingQuality Management System (QMS)Configuration ManagementUser Acceptance Testing (UAT)Compliance Strategy DevelopmentPolicy Development
Soft skills
Team LeadershipCoachingMentorshipPerformance ManagementCross-Functional CollaborationStrategic InfluenceCommunicationProblem Solving
Certifications
Qualified Lead Auditor