Global PDM Program Expert - Process & Data Excellence

360Pharma

Beerse

Sur place

EUR 65 000 - 85 000

Plein temps

Il y a 4 jours
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Résumé du poste

360Pharma seeks a Specialist, Process & Data Management (PDM) Program Expert to join the Quality Management & Digital team. You will translate regulatory requirements into compliant, scalable processes and learning solutions across global R&D.

You will lead ARR and Quality Framework initiatives, develop training materials, map end-to-end processes, and collaborate with Therapeutic Areas, Clinical Development, Medical Safety, Regulatory Affairs, and R&D Quality to drive improvements.

Qualifications

  • Bachelor’s degree required; science or business background preferred.
  • 1–3 years of experience in a medium-to-large matrix organization.
  • Pharma/R&D environment experience is desirable.
  • Knowledge of global pre-clinical and clinical compliance is a plus.

Responsabilités

  • Lead ARR and Quality Framework Integration initiatives.
  • Analyze, develop, implement and integrate compliant end-to-end processes.
  • Develop and maintain training and qualification materials.
  • Perform requirement comparison and integration across the QMS.
  • Contribute to content management and qualification transformation.
  • Align business requirements with regulatory expectations.
  • Support changes, CAPAs, inspections, and regulatory requests.
  • Drive project timelines, deliverables, and risk management.

Connaissances

Strong collaboration
Quality Management System knowledge
Data-centric content
Process analysis
Training design
Attention to detail
Project management
Effective communication

Formation

Bachelor’s degree in Science, Business, or related field

Outils

Microsoft Office Suite

Description du poste

360Pharma seeks a Specialist, Process & Data Management (PDM) Program Expert to join the Quality Management & Digital team. You will translate regulatory requirements into compliant, scalable processes and learning solutions across global R&D.

You will lead ARR and Quality Framework initiatives, develop training materials, map end-to-end processes, and collaborate with Therapeutic Areas, Clinical Development, Medical Safety, Regulatory Affairs, and R&D Quality to drive improvements.

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