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Work Schedule
Standard (Mon-Fri)Environmental Conditions
Office
Job Description
- The Global Patient Safety (GPS) Quality Management Manager is responsible for the operational execution of the Pharmacovigilance (PV) Quality Management System (QMS) in a consistent, effective and efficient way within the Global Patient Safety functional area.
- This position will also:
- Contribute to driving the growth of the GPS Quality Management function.
- Maintain & execute the Comprehensive Training Program.
- Manage GPS Procedural Document activities
- Participate in GPS Audit & Inspection Readiness, Support & Management.
- Contribute to GPS Continuous Improvement (Issue Management, Process improvement, KPI development).
- Associate Director, GPS Quality Management or above

GPV internal Audit program and Inspection activities:
- Support, and/or manage GVP Audit & Inspection activities




- Support internal general GVP audit program and inspection readiness activities in collaboration with the client Quality functional area.
- Prepare GPS team members on inspection readiness activities.
- Ensure appropriate documents are readily retrievable to use during an Inspection (GPS inspection slides, CVs, JDs, PVAs are contact information is updated and readily available).
- Support the coordination and preparation of GPS responses to audit &inspection; findings.

Deviation & Corrective and Preventive Action (CAPA) activities:
- Assess GPS issue management trends and implement actions plans to mitigate systemic causes.
- Identify internal deviations and support / advise GPS team in determining corrective and preventive actions.
- Support/guide the GPS team to determine root cause of issue to avoid recurrence.
- In collaboration with the client Quality functional area, lead the implementation of

📌 FSP Quality Manager (España)
🏢 Thermo Fisher Scientific
📍 España