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Job Description
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.
How you contribute
- 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.
What you bring to Takeda
- 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.
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, fosters an inclusive, collaborative workplace, with a commitment to deliver Better Health and a Brighter Future.
Empowering our people to shine
Takeda is proud of 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
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location: Lexington, MA
U.S. Base Salary Range: $174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on qualifications, experience, skills, and location. U.S. based employees may be eligible for incentives and benefits described.
EEO Statement
Takeda is proud of 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.
Locations
Lexington, MA; Glattpark (Opfikon) - Zurich HQ
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt: Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to penalties.
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