Senior Expert Science & Technology, Polarion Business Lead, GDPD (m/f/d)
Core
Lead Polarion as a critical, GMP-compliant, cross-functional platform for product development and lifecycle management in drug-device combination products.
Role type
Senior Business Lead / Platform Owner
Builds
GMP-compliant digital design controls, end-to-end traceability, Design History File practices, and document automation.
Domain
Life Sciences / Medical Devices / Regulatory Compliance (GxP)
Required skills
Polarion ALM (configuration, scripting, macros), GxP/regulated environment experience, Design controls & Design History File knowledge, Cross-functional leadership, Project management, English fluency
Preferred skills
Master's degree in Life Sciences/Engineering/CS, Experience with drug-device combination products
Technologies
Polarion ALM
Responsibilities
Lead the GDPD Polarion network and facilitate key-user forums; Design and operationalize Polarion enhancements; Coordinate releases and defect resolution; Define and deliver training programs; Support onboarding of new device projects; Partner with functions to maximize Design History File synergies; Prepare budget proposals and track spending; Ensure compliant operation and audit readiness; Define and monitor KPIs; Author and maintain procedures.
Seniority
Senior, hands-on IC with leadership scope
