Hybrid Polarion Platform Lead for GMP & Design Controls

Novartis AG

Tirol

Hybrid

EUR 67,000 - 118,000

Full time

5 days ago
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Benefits offered by this job

Hybrid working options
Parental leave 14 weeks
Wellbeing resources
Insurance and retirement plans

Job summary

Novartis AG in Austria seeks a Senior Expert Science & Technology to lead GDPD Polarion as a critical, GMP-compliant platform for product development and lifecycle management. You will steer the Polarion network, shape the roadmap and translate business needs into system enhancements.

The role combines hands-on Polarion expertise with business leadership across functions, ensuring harmonized Design History File practices, document automation and project delivery within a hybrid work setup.

Qualifications

  • Bachelor's degree or equivalent in Life Sciences, Engineering, Computer Science or related field.
  • Experience with Polarion ALM including configuration, scripting/macros, or templates.
  • Experience in regulated GxP or medical-device environments with quality and change control.

Responsibilities

  • Lead the GDPD Polarion network including Polarion Business Support and key users.
  • Design and operationalize enhanced Polarion capabilities; own enhancement backlog and intake.
  • Coordinate releases, changes and defect resolution with support teams and external Polarion specialists.
  • Define and deliver Polarion training; develop central knowledge base and self-service.
  • Support onboarding of new device projects; promote reuse of blueprints and cross-project harmonization.
  • Partner with functions to maximize Design History File synergies and alignment with design controls.
  • Prepare budget proposals for enhancements and external support; contribute to roadmap.
  • Ensure compliance with quality, regulatory, information security, health, safety and environmental requirements; drive improvement and audits.
  • Define KPIs and address capability or compliance gaps; author procedures and work instructions for Polarion.

Skills

Polarion ALM
GxP experience
Cross-functional leadership
Project management
Communication skills
English language

Education

Bachelor's degree in Life Sciences/Engineering/CS
Master's degree desirable

Tools

Polarion ALM
Polarion scripting/macros

Job description

Novartis AG in Austria seeks a Senior Expert Science & Technology to lead GDPD Polarion as a critical, GMP-compliant platform for product development and lifecycle management. You will steer the Polarion network, shape the roadmap and translate business needs into system enhancements.

The role combines hands-on Polarion expertise with business leadership across functions, ensuring harmonized Design History File practices, document automation and project delivery within a hybrid work setup.

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