Head Global Quality Digital Health and Artificial Intelligence Compliance

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About the role

As the Head Global Quality Digital Health and Artificial Intelligence Compliance (Open), you will provide enterprise-wide leadership, governance, and oversight for digital health, Artificial Intelligence (AI), and Machine Learning (ML) across Takeda’s Quality organization. You will ensure regulatory compliance, data integrity, and the sustainable integration of AI-driven technologies across GxP and non-GxP environments. Working cross-functionally, you will drive consistency, continuous improvement, and harmonization of digital health and AI practices across the global network.

You will also establish governance structures, performance indicators, and communities of practice to enhance quality decision-making and sustain compliance excellence.

• Establishes a comprehensive Takeda Enterprise-wide quality approach for the implementation of regulations, policies, procedures, and guidances related to digital health and the use of AI/ML.
• Oversees the usage of AI in data management, data use in AI applications and analytics, ensuring compliance and data integrity throughout the data lifecycle.
• Collaborates with various functions across Takeda to ensure a consistent and holistic approach for GxP and non-GxP digital health applications and AI compliance across the enterprise.
• Liaises with other functions to develop a structure that enables GxP compliance sustainability of all processes, improvement activities, and technologies for areas under this function.
• Provides expert support to the network with regulatory inspections and responses to Health Authorities.
• Responsible for establishing practices for GxP and non-GxP data that enhance decision-making and regulatory compliance by assuring appropriate use of digital health applications and AI/GenAI practices as enablers in quality decision-making.
• Establishes KPIs to identify trends and opportunities to proactively improve and sustain compliance excellence across Takeda.
• Establishes and/or supports Communities of Practice to promote enterprise-wide data management understanding and compliance.
• Oversees Business Process/System Owners for Digital Health and AI to ensure consistency of approach across the network.
• Provides input to GQ Compliance to help shape priorities.

• Bachelor’s degree in a relevant scientific or technical field; advanced degree in Data Management, Digital Health, Data Governance, or AI/GenAI preferred.
• Minimum of 15 years of experience in the life sciences industry, including at least 10 years in computerized systems, Data Integrity, and Quality Systems; AI/GenAI and Data Governance experience highly desired.
• Strong leadership capabilities with proven success in guiding cross-functional and global teams toward strategic goals.
• Deep expertise in Data Governance, Master Data Management, AI/GenAI applications, and Data Integrity principles.
• Excellent analytical, critical thinking, and problem-solving skills with a track record of effective decision-making in complex environments.
• Exceptional communication, influencing, and negotiation skills, fostering trust and collaboration across diverse stakeholders.
• Business acumen with the ability to understand and align with corporate strategy, financial objectives, and compliance requirements.
• Comprehensive understanding of Good Manufacturing Practices (GxP), global regulatory expectations, and experience with Health Authority inspections and responses.
• Commitment to innovation and digitalization, fostering continuous improvement, environmental sustainability, and patient-centric outcomes.
• Fluent in English (written and spoken) with willingness and ability to travel internationally as required.

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