Job Description

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



Apply now