Global Quality Governance Specialist
5 dagen geleden
Santen is a specialized life sciences company with a 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with a footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues worldwide.
Key Responsibilities- BUILDING A STRONG QUALITY GOVERNANCE STRUCTURE: Establish an effective EMEA Regional Quality Governance Structure to ensure that EMEA Quality Management System (QMS) processes function properly and continuous improvement is achieved.
- LEADING AUDIT MANAGEMENT: Roll out the consolidated supplier risk assessment and audit plan across the EMEA QA Functions.
- DIGITAL TRANSFORMATION: Deploy new Risk Management across the EMEA QA Functions and drive risk mitigation activities.
- TRAINING AND DEVELOPMENT: Establish an EMEA Learning Management System Training Matrix covering GxP/ISO.
- COMPLIANCE AND REGULATORY AFFAIRS: Play a key role in quality management system-related activities to ensure continuous compliance of Santen EMEA to applicable EU pharma, distribution, and medical devices regulations (EU GDP, MDD/MDR, ISO13485).
- EXPERIENCE IN PHARMACEUTICAL OR MEDICAL DEVICE INDUSTRY: 5+ years of experience working in Pharmaceutical, Medical Device industry or related area.
- USE OF MICROSOFT OFFICE TOOLS: Proficiency in Microsoft office tools.
- e-QMS TOOLS: Experience with e-QMS tools such as Veeva, Trackwise.
- GxP AUDITING AND RISK ASSESSMENT: Knowledge and experience of GxP Auditing and Risk Assessment.
- ENHANCED IT SYSTEM SKILLS: Strong IT system skills, including SAP, SAP Quality Module, Power BI.
- QUALITY MANAGEMENT SYSTEMS: Knowledge and experience of quality management systems (QMS).
- BACHELOR'S DEGREE IN CHEMISTRY OR LIFE SCIENCE AREA: Bachelor's degree in chemistry, pharmaceutical, biotechnology, or life science area.
The estimated salary range for this position is approximately €80,000 - €110,000 per year, depending on experience and qualifications.
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