Work Schedule

Si le interesa solicitar este empleo, por favor, asegúrese de cumplir los siguientes requisitos que se enumeran a continuación.

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description
1PURPOSE OF THE FUNCTION

-

- The General 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 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)

- Manage GPS Procedural Document activities including contributing, developing, reviewing, and continually improving GPS process & procedures.





- Participate in cross functional Procedural Document activities/forums to determine relevance to GPS and assure appropriate GPS input and review are provided.

- Support document control through use of Veeva System.

GPS Performance & Compliance activities

-

- Contribute to development & subsequent evaluation of Key Performance Indicators and adapt them to reflect the evolving business needs.

- Support monitoring of compliance to 3rd party contractual obligations/PVAs and determine if there are gaps or non-conformities and report appropriately into GPS staff

- 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

Other Activities:

-

- Perform other tasks and duties as assigned by line manager or GPS Leadership

4SKILLS AND COMPETENCIES

-

- Excellent planning and organizational skills.

- Excellent oral and written communication skills.

- Ability to work in global environment.

- Solution oriented with ability to prioritize and work independently.

- Robust presentation skills with the ability to communicate complex issues clearly.

- Demonstrated ability to author and contribute to procedural documents.

- Ability to motivate and collaborate with multidisciplinary teams.

- Relevant computer skills, including proficiency with Microsoft Office and tracking data

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