This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Environmental Conditions
Office
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.
Contribute to driving the growth of the GPS Quality Management function.
Maintain & execute the Comprehensive Training Program.
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

Support internal integral GVP audit program and inspection readiness activities in collaboration with the client Quality functional area.
Assess GPS issue management trends and implement actions plans to mitigate systemic causes.
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 training program.
Maintain, expand, and deliver the pharmacovigilance training program (procedural documents, inspection readiness, refresher training, etc).




Work closely with key stakeholders to support and/or implement pharmacovigilance training across the organization.
Support the monitoring, maintaining, re-evaluating and updating the GPS training curricula
Provide training to relevant client employees and 3rd parties (when applicable)
Participate in cross functional Procedural Document activities/forums to determine relevance to GPS and assure appropriate GPS input and review are provided.
GPS Performance & Compliance activities
Contribute to development & subsequent evaluation of Key Performance Indicators and adapt them to reflect the evolving business needs.
Liaise with the QA Department regarding GPS quality & compliance requirements/deliverables.
Support monitoring the status of and compliance with GPS Standard Operating Procedures (SOPs) and other controlled documents.
Support the compliance monitoring of the pharmacovigilance agreements (PVAs), Safety Data Exchange Agreements (SDEAs) and other agreements as applicable with business partners
Excellent planning and organizational skills.
Ability to work in global environment.
Relevant computer skills, including proficiency with Microsoft Office and tracking databases.
Fluency in written and spoken English.
At least Bachelor's degree in pharmacy, nursing, healthcare or other life-science or technical field or country equivalent combination of education and experience
Good track record of operating pharmacovigilance quality systems, processes and teams
Knowledge of GXP quality and compliance requirements, processes and measures.

📌 Quality coordinator. (España)
🏢 Thermo Fisher Scientific
📍 España