Senior Qa Operations Expert; Qualified Person (m/f/d)
Novartis UK
Schaftenau, Austria
Minimum: €73,122.90pyear; actual: higher based on ...
Hybrid
Qualified person certification under ambo 2009
Cgmp and gxp regulatory compliance expertise
Batch release management and disposition authority
The Qualified Person is legally accountable for the final certification and release of medicinal products in Austria ensuring full compliance with national and EU regulations
Job Summary
The Qualified Person is legally accountable for the final certification and release of medicinal products in Austria ensuring full compliance with national and EU regulations.
This role requires leading critical negotiations, managing technical operations execution, and overseeing project delivery while maintaining strict adherence to GMP standards.
Candidates will benefit from working at one of Novartis's most modern manufacturing sites in the Austrian Alps with a competitive salary starting at €73,122.90 per year.
Matching Summary
The Qualified Person is legally accountable for the final certification and release of medicinal products in Austria ensuring full compliance with national and EU regulations.
Salary
Minimum: €73,122.90/year; Actual: Higher based on experience; Benefits: Competitive market position
Skills & Requirements
Must-have
Qualified Person certification under AMBO 2009
cGMP and GxP regulatory compliance expertise
Batch release management and disposition authority
Audit and inspection readiness coordination
Technical operations leadership in pharmaceuticals
Nice-to-have
Strong people leadership and coaching capabilities
Experience with digital proficiency and data integrity
Ability to navigate ambiguity effectively
Cross-functional collaboration skills
Continuous improvement focus in quality systems
Key Requirements
Proven experience in Audit and Inspection Management
Hands-on experience with Release Management processes
Solid expertise in Quality Management Systems (QMS)
Background in Technical Operations with technological aptitude
Demonstrated people leadership capability in patient-focused environment