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 development of the Pharmacovigilance trai

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