Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

1PURPOSE OF THE FUNCTION
- The Integral 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).

2REPORTING LINE
- Associate Director, GPS Quality Management or above

3ROLES AND RESPONSIBILITIES

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




- Support internal global 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 corrective or preventive actions.

Training, Procedural Document, & Record Management activities:
- Contribute to the deve

📌 FSP Quality Manager (España)
🏢 ThermoFisher Scientific
📍 España