Bei Daiichi Sankyo stehen wir vereint hinter einem einzigen Ziel: Das Leben auf der ganzen Welt durch innovative Medikamente zu verbessern. Mit aktiver Innovation seit 1899, Präsenz in mehr als 30 Ländern und über 19.000 Mitarbeitern entwickeln wir bahnbrechende Therapien in der Onkologie, für Herz-Kreislauf-Erkrankungen, seltene Krankheiten und Immunerkrankungen. Im Einklang mit unserer Vision 2030, "ein innovatives globales Gesundheitsunternehmen zu sein, das zur nachhaltigen Entwicklung der Gesellschaft beiträgt", gestalten wir eine gesündere, hoffnungsvollere Zukunft für Patienten, ihre Familien und die Gesellschaft.
We are seeking a dynamic and experienced Project Lead to drive the rollout of Daiichi Sankyo’s global electronic document management system (eDMS) within the EUCAN region. This role offers the opportunity to lead a critical initiative that enhances GxP document management processes across multiple countries, working closely with key stakeholders including System Owners and Quality Assurance teams.
This position is based at our Munich or Pfaffenhofen site.
Roles and Responsibilities
- Analyze existing business processes related to GxP document management in the EUCAN region.
- Collaborate closely with the System Owner and QA Systems representatives to develop a comprehensive migration strategy into the eDMS.
- Plan, coordinate, and lead the end-to-end rollout of the Daiichi Sankyo global eDMS across the EUCAN region.
- Develop and issue detailed Business Requirement Specifications (BRS) for GxP document management processes.
- Review and provide input on Design and Test documentation for the eDMS implementation.
- Lead and execute user acceptance testing (UAT) to ensure system functionality and compliance.
- Partner with Process Leads to design effective training concepts and develop training materials tailored for users in the EUCAN region.
Skills and additional Requirements
- Minimum of 5 years’ experience in Quality Management within the pharmaceutical industry.
- Proven track record in implementing software solutions for quality management processes.
- Demonstrated experience in successfully leading complex projects.
- In-depth knowledge of GMP and GDP regulations, specifically related to GxP document management.
- Strong affinity for electronic systems, including their structure and implementation.
- Exceptional analytical skills with meticulous attention to detail. Ability to communicate complex concepts clearly to diverse stakeholders.
- Fluent in both German and English, with excellent verbal and written communication skills.
- Strong interpersonal skills with the ability to collaborate effectively within international and cross-functional teams.
