Takeda · 2 days ago
Head Global Quality Digital Health and Artificial Intelligence Compliance
Lexington, MA
Full-time
Onsite
Director/Executive
$174K/yr - $274K/yr
15+ years expTakeda is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. As the Head Global Quality Digital Health and Artificial Intelligence Compliance, you will provide leadership and oversight for digital health and AI compliance, ensuring regulatory adherence and data integrity across the organization.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
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
Qualification
Required
Bachelor's degree in a relevant scientific or technical field
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
Preferred
advanced degree (BSc, MSc, PhD) in Data Management, Digital Health, Data Governance, or AI/GenAI
Benefits
Short-term and/ or long-term incentives
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-22
2026-01-19
2026-01-14
Company data provided by crunchbase