GxP Quality & Training Lead (LMS & QMS)

Novo Nordisk Foundation

Kongens Lyngby

On-site

DKK 650,000 - 850,000

Full time

13 days ago
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Job summary

Cellerator, Lyngby, Denmark, is seeking a QMS & Training Specialist to join the Quality Assurance team. You will establish and develop our training framework, electronic training system, and broader quality processes to ensure the right training and competencies in a GxP-regulated environment.

This hands-on role focuses on implementing the electronic training management system and sets the stage for broader QMS activities.

Qualifications

  • Bachelor's or Master's degree in Life Sciences or related field.
  • 5+ years in a GxP-regulated pharmaceutical/biotech/ATMP environment.
  • 2+ years supporting training management, LMS, or qualification processes.
  • Experience with QMS and GxP compliance requirements.
  • Strong stakeholder management and cross-functional collaboration.
  • Proactive, pragmatic mindset in a growing scale-up environment.

Responsibilities

  • Establish and develop the GxP training framework and electronic training system with the QA team.
  • Partner with managers to develop role-based curricula and competency requirements.
  • Monitor training compliance and onboarding/qualification of new employees.
  • Contribute to continuous improvement of the Quality Management System, including deviations, CAPAs, change controls, and document management.
  • Help shape scalable quality and training processes in a growing cell therapy scale-up.

Skills

GxP compliance
QMS experience
LMS / training management
Stakeholder management
Cross-functional collaboration
Quality Management System exposure
Cell therapy / ATMP knowledge

Education

Bachelor's or Master's degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, Quality Management, or related

Job description

Cellerator, Lyngby, Denmark, is seeking a QMS & Training Specialist to join the Quality Assurance team. You will establish and develop our training framework, electronic training system, and broader quality processes to ensure the right training and competencies in a GxP-regulated environment.

This hands-on role focuses on implementing the electronic training management system and sets the stage for broader QMS activities.

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