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GPS Quality Manager
argenxGlobal Patient Safety Quality Manager managing pharmacovigilance quality systems in the pharmaceutical industry. Driving training programs, audit readiness, and compliance improvements for automated patient safety.
About the role
Key responsibilities & impact- Drive the growth of the GPS Quality Management function
- Drive & Implement the Comprehensive Training Program
- Manage GPS Procedural Document activities
- Actively participate in and coordinate GPS Audit & Inspection Readiness, Support & Management
- Drive GPS Continuous Improvement (Issue Management, Process improvement, KPI development)
- Coordinate and manage GVP Audit & Inspection activities
- Engage in internal global GVP audit program and inspection readiness activities
- Prepare GPS team members on inspection readiness activities
- Assess GPS issue management trends and develop/implement actions plans to mitigate systemic causes
- Guide the GPS team to determine root cause of issues to avoid recurrence
- Develop, expand, and deliver the pharmacovigilance training program
- Manage GPS Procedural Document activities including contributing, developing, reviewing, and continually improving GPS processes & procedures.
Requirements
What you’ll need- At least Bachelor’s degree in pharmacy, nursing, healthcare or other life-science or technical field
- At least 7 years of experience in the pharmaceutical/biotech industry with at least 5 years in relevant pharmacovigilance/drug safety field
- Proven track record of establishing or managing pharmacovigilance quality systems, processes and teams
- Robust experience with preparing for, hosting and responding to audits and regulatory inspections globally
- Solid working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan)
- Expert knowledge of GXP quality and compliance requirements, processes and measures.
Benefits
Comp & perks- Comprehensive benefits package, including health benefits
- Retirement savings plans
- Short-term and long-term incentive programs
ATS Keywords
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Hard Skills & Tools
PharmacovigilanceQuality ManagementRegulatory ComplianceProcess ImprovementKPI DevelopmentRoot Cause AnalysisDocument ManagementTraining Program ImplementationAudit PreparationIssue Management