Head Global Quality – Digital Health, Artificial Intelligence Compliance
Takeda
full-time
Posted on:
Location Type: Office
Location: Lexington • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $174,500 - $274,230 per year
Job Level
Lead
About the role
- Provide enterprise-wide leadership for digital health, AI, and ML across Takeda’s Quality organization
- Ensure regulatory compliance, data integrity, and sustainable integration of AI-driven technologies
- Drive consistency, continuous improvement, and harmonization of digital health and AI practices
- Establish governance structures and performance indicators
- Collaborate with various functions to enable GxP compliance sustainability
- Provide expert support during regulatory inspections
- Establish practices for GxP and non-GxP data
- Identify trends and opportunities to improve compliance excellence
- Support Communities of Practice for enterprise-wide data management compliance
- Oversee Business Process/System Owners for consistency across the network
- Provide input to GQ Compliance to help shape priorities
Requirements
- Bachelor’s degree in a relevant scientific or technical field; advanced degree (BSc, MSc, PhD) 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
- Exceptional communication, influencing, and negotiation skills
- Business acumen with the ability to understand and align with corporate strategy
- Comprehensive understanding of Good Manufacturing Practices (GxP) and experience with Health Authority inspections
- Fluent in English (written and spoken) with willingness and ability to travel internationally
Benefits
- Medical, dental, and vision insurance
- 401(k) plan with company match
- Short-term and long-term disability coverage
- Basic life insurance
- Tuition reimbursement program
- Paid volunteer time off
- Company holidays
- Well-being benefits
- Sick time and paid vacation
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
AIMLData IntegrityQuality SystemsData GovernanceMaster Data ManagementGxPData Management ComplianceDigital HealthRegulatory Compliance
Soft skills
leadershipanalytical skillscritical thinkingproblem-solvingcommunicationinfluencingnegotiationbusiness acumencollaborationstrategic thinking
Certifications
Bachelor's degreeMaster's degreePhD