We are seeking a highly qualified candidate to fill the position:

Regional Process Lead (m/f/x) eQMS

Roles and Responsibilities:

• Regional accountability for overseeing and enhancing eQMS system processes to ensure operational efficiency and transparency
• Drive standardization of the assigned system processes – both in the area of GMP and GDP
• Collaborate closely with the regional Business Process Owner
• Continuously monitor process performance and derive measures for process improvement in close cooperation with various global and regional stakeholders
• Support implementation of best practice standards and ensure compliance with quality and regulatory requirements in your own area of responsibility
• Collaborate closely with global Process Leads and actively contribute to shaping global eQMS system
• Ensure continuous operational readiness of system processes by maintaining up-to-date documentation, including procedures, templates, and work instructions within DSE
• Develop and deliver training for employees for the assigned system processes

Personal skills and professional experience:

• Completed studies in natural sciences / pharmaceutical sciences or a comparable qualification
• 5+ years of relevant professional experience in a GMP/GDP-regulated environment
• Experience with electronic QM systems (e.g., TrackWise Digital, Veeva Quality Vault, etc.)
• Experience with computer system validation is a plus
• Excellent communication skills and experience in stakeholder management
• Strong analytical skills and attention to detail, with the ability to communicate complex matters/concepts to various stakeholders
• Very good knowledge of relevant regulations from various authorities (e.g., EMA, SwissMedic, MHRA, Health Canada, etc.)
• Excellent German and English skills, both written and spoken