Senior Expert Quality Management International (m/w/d)
Core
Senior expert leading the development, maintenance, and implementation of the international Quality Management System (QMS) for medical devices and pharmaceutical quality requirements, ensuring regulatory compliance and audit readiness globally.
Role type
Senior IC Quality Management Systems Expert (Medical Devices/Pharma)
Builds
International QMS for medical devices and GxP-regulated processes
Domain
Healthcare / Medical Devices / Pharmaceuticals / Regulatory Affairs
Required skills
QMS implementation and maintenance, GxP regulations (GMP, GDP), ISO 13485, MDSAP, regulatory interpretation, audit preparation and coordination, strategic initiative management, ERP and workflow systems, team leadership in international structures
Preferred skills
Pharmaceutical industry experience, additional languages beyond English and German
Technologies
MS Office, ERP systems, Workflow solutions
Responsibilities
Support implementation and continuous improvement of the international QMS, monitor implementation status across business units, ensure regulatory compliance and audit readiness, prepare for and coordinate regulatory inspections and certification audits, report on QMS KPIs to management, ensure necessary certifications and licenses are in place
Seniority
Senior, hands-on IC with leadership responsibilities
