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Daiichi Sankyo Europe GmbH
Project Lead QA (m/w/d) electronic Document Management SystemDaiichi Sankyo Europe GmbH • Pfaffenhofen an der Ilm, Bavaria, Germany
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Daiichi Sankyo Europe GmbH

Project Lead QA (m/w/d) electronic Document Management System

Daiichi Sankyo Europe GmbH
  • DE
    Pfaffenhofen an der Ilm, Bavaria, Germany
  • DE
    Pfaffenhofen an der Ilm, Bavaria, Germany
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À propos

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Project Lead QA (m/f/d) electronic Document Management System

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.


  • 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.

  • 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.

  • Excellent Benefits
  • Work-Life Balance
  • Growth and Development
  • Health and Wellbeing Support

  • Pfaffenhofen an der Ilm, Bavaria, Germany

Compétences linguistiques

  • English
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