Regional QA Process Lead

vor 1 Woche


München, Deutschland Daiichi Sankyo, Inc. Vollzeit

** Regional QA 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


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