BioSpace
Head Global Quality Digital Health and Artificial Intelligence Compliance
BioSpace, Lexington, Massachusetts, United States, 02173
Head Global Quality Digital Health and Artificial Intelligence Compliance
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.
Responsibilities
Establish 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.
Oversee 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.
Collaborate 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.
Liaise and partner 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.
Provide expert support to the network as needed with regulatory inspections and responses to Health Authorities regarding areas under this function.
Establish 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.
Establish 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.
Establish and/or support Communities of Practice to ensure and promote enterprise-wide data management understanding and compliance.
Oversee Business Process/System Owners for Digital Health and Artificial Intelligence to ensure consistency of approach across the network.
Provide 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.
More About Us At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering Our People To Shine Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.
Takeda Compensation And Benefits Summary Location: Lexington, MA U.S. Base Salary Range: $174,500.00 - $274,230.00 U.S. based employees may be eligible for short-term and/or long-term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, well-being benefits, up to 80 hours of sick time, and new hires accrue up to 120 hours of paid vacation.
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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Responsibilities
Establish 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.
Oversee 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.
Collaborate 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.
Liaise and partner 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.
Provide expert support to the network as needed with regulatory inspections and responses to Health Authorities regarding areas under this function.
Establish 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.
Establish 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.
Establish and/or support Communities of Practice to ensure and promote enterprise-wide data management understanding and compliance.
Oversee Business Process/System Owners for Digital Health and Artificial Intelligence to ensure consistency of approach across the network.
Provide 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.
More About Us At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering Our People To Shine Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.
Takeda Compensation And Benefits Summary Location: Lexington, MA U.S. Base Salary Range: $174,500.00 - $274,230.00 U.S. based employees may be eligible for short-term and/or long-term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, well-being benefits, up to 80 hours of sick time, and new hires accrue up to 120 hours of paid vacation.
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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