PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Communication to the Editor
Digital Talent Development for Digital Transformation (DX) in Pharmaceutical Manufacturing
PDA Japan Chapter, DX Group in Kansai Study GroupKenji TAKAIShigeki TOGEHirotsugu ATSUMARUTsutomu KAMIKUKITAHironori OCHIAITakuro KAYAKenta GOTOOsamu SHIROKIZAWAJun NAKAJIMAHidetaka HOKAOKazuhide YAMAMOTONorio YANAGISAWA
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2026 Volume 28 Issue 1 Pages 54-68

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Abstract

Proposal for Digital Talent Development to Promote Digital Transformation in Pharmaceutical Manufacturing. Japan’s digital transformation (DX) is considered to be lagging behind Western countries, particularly in pharmaceutical manufacturing, where conservative corporate culture and regulatory complexity hinder progress. This proposal emphasizes human resource development as the key to successful DX implementation. We define seven essential roles—Business Architect, Designer, Data Scientist, Software Engineer, Cybersecurity Specialist, Data Steward, and CSQA (Computer System Quality Assurance)—and outline their responsibilities, tasks, and required skills. By fostering these roles, pharmaceutical companies can enhance DX quality, strengthen global competitiveness, and establish sustainable organizational frameworks. This proposal presents a conceptual framework aimed at providing practical guidance and recommendations for accelerating DX in the pharmaceutical industry.

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© 2026 Parenteral Drug Association Japan Chapter
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