Head Global Quality Digital Health and Artificial Intelligence Compliance
Scorpion Therapeutics, Lexington, Massachusetts, United States, 02173
Role Summary
Head Global Quality Digital Health and Artificial Intelligence Compliance at Takeda based in Lexington, MA. You will provide enterprise-wide leadership, governance, and oversight for digital health, Artificial Intelligence (AI), and Machine Learning (ML) across Takeda’s Quality organization, ensuring regulatory compliance and data integrity across GxP and non-GxP environments. You will drive consistency, continuous improvement, and harmonization of digital health and AI practices across the global network, establishing governance structures and communities of practice to sustain compliance excellence.
Responsibilities
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 Artificial Intelligence and Machine Learning.
Oversees the usage of Artificial Intelligence (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, including Data Governance, Computerized Systems Quality, Global and Operational DD&T functions, Regulatory Affairs, and Operational functions, to ensure a consistent and holistic approach for GxP and non-GxP digital health applications and Artificial Intelligence compliance across the Takeda Enterprise.
Liaises and partners with other functions such as Supply Chain, R&D Quality, BioLife, DD&T, Regulatory, and Engineering to develop a structure that will enable GxP compliance sustainability of all processes, improvement activities, and technologies for areas under this function.
Provides expert support to the network as needed with regulatory inspections and responses to Health Authorities regarding areas under this function.
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 Artificial Intelligence and Machine Learning, including AI/GenAI practices, as enablers in quality decision-making.
Establishes appropriate mechanisms, including KPIs, to identify trends, patterns, and opportunities to take proactive measures to continuously improve and sustain compliance excellence across the Takeda Enterprise.
Establishes and/or supports Communities of Practice to ensure and promote enterprise-wide data management understanding and compliance.
Oversees Business Process/System Owners for Digital Health and Artificial Intelligence to ensure consistency of approach across the network.
Provides input to GQ Compliance to help shape priorities.
Qualifications
Bachelor’s degree in a relevant scientific or technical field; advanced degree (BSc, MSc, PhD) in Data Management, Digital Health, Data Governance, or AI/GenAI preferred.
Minimum of 15 years of experience in the life sciences industry (pharma/biotech/devices), 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 and global functions.
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.
Demonstrated 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.
Education
Bachelor’s degree in a relevant scientific or technical field; advanced degree in related areas preferred.
Additional Requirements
Willingness and ability to travel internationally as required.
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Responsibilities
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 Artificial Intelligence and Machine Learning.
Oversees the usage of Artificial Intelligence (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, including Data Governance, Computerized Systems Quality, Global and Operational DD&T functions, Regulatory Affairs, and Operational functions, to ensure a consistent and holistic approach for GxP and non-GxP digital health applications and Artificial Intelligence compliance across the Takeda Enterprise.
Liaises and partners with other functions such as Supply Chain, R&D Quality, BioLife, DD&T, Regulatory, and Engineering to develop a structure that will enable GxP compliance sustainability of all processes, improvement activities, and technologies for areas under this function.
Provides expert support to the network as needed with regulatory inspections and responses to Health Authorities regarding areas under this function.
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 Artificial Intelligence and Machine Learning, including AI/GenAI practices, as enablers in quality decision-making.
Establishes appropriate mechanisms, including KPIs, to identify trends, patterns, and opportunities to take proactive measures to continuously improve and sustain compliance excellence across the Takeda Enterprise.
Establishes and/or supports Communities of Practice to ensure and promote enterprise-wide data management understanding and compliance.
Oversees Business Process/System Owners for Digital Health and Artificial Intelligence to ensure consistency of approach across the network.
Provides input to GQ Compliance to help shape priorities.
Qualifications
Bachelor’s degree in a relevant scientific or technical field; advanced degree (BSc, MSc, PhD) in Data Management, Digital Health, Data Governance, or AI/GenAI preferred.
Minimum of 15 years of experience in the life sciences industry (pharma/biotech/devices), 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 and global functions.
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.
Demonstrated 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.
Education
Bachelor’s degree in a relevant scientific or technical field; advanced degree in related areas preferred.
Additional Requirements
Willingness and ability to travel internationally as required.
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