Expert (m/w/d) quality systems

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.

Purpose of the function

For our Daiichi Sankyo Europe GmbH headquarters in Munich we are currently seeking highly qualified candidates to fill the position:

Expert (m/w/d) Quality Systems

Roles and Responsibilities

• Serve as Regional Administrator for electronic quality management tools like document management system and training management system
• Perform first level support for all users of Regional electronic quality management tools
• Support Regional Process Leads und Process Owners in continuous monitoring of process performance and process optimization projects
• Deputy Regional Process Leads and Process Owners in Regional meetings and projects
• Support implementation of best practice standards and ensure compliance with quality and regulatory requirements
• Support document and training material creation
• Support migration and testing activities for computerized systems

Personal skills and professional experience:

• Completed studies in natural sciences / pharmaceutical sciences or a comparable qualification
• 2+ years of relevant professional experience in a GMP/GDP-regulated environment
• Experience with electronic quality management systems in GMP/GDP environments (e.g. Veeva Vault, TrackWise Digital, Compliance Wire, SAP S4)
• Experience with user acceptance testing for computer system validation is a plus
• Excellent communication skills
• Strong attention to detail and highly focussed on a right-first-time concept
• 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

Why work with us?

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

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