Project Lead QA (electronic Document Management System)

Responsibilities

• Analyze existing business processes related to GxP document management in the EUCAN region
• Collaborate with System Owners and QA Systems representatives to develop migration strategies into the eDMS
• Plan, coordinate, and lead the end-to-end rollout of the 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 training concepts and develop materials tailored for regional users

Requirements

• Minimum of 5 years of 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 regarding GxP document management
• Strong affinity for electronic systems, including their structure and implementation
• Exceptional analytical skills and meticulous attention to detail
• Fluent in both German and English (verbal and written)
• Strong interpersonal skills for collaborating within international and cross-functional teams

About the Company

Daiichi Sankyo is a global healthcare company dedicated to improving lives through innovative medicines. With a legacy dating back to 1899 and a presence in over 30 countries, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. We foster a culture of mutual respect, continuous learning, and inclusion to shape a healthier future for patients worldwide.