Business System Owner – Quality System

Role Summary

As Business System Owner – Quality System, you will drive the design, implementation, and deployment of the DMS (Document Management System) & LMS (Learning Management System) electronic systems. You will be the business owner of these enterprise quality systems, advancing the digital quality landscape and supporting the transformation of the Global Quality organization through innovative thinking and digital solutions.

Responsibilities

• Lead the implementation and ongoing management of enterprise-level quality systems, ensuring alignment with global standards and compliance requirements
• Collaborate with business partners to enhance workflows, resolve issues, and support the DMS and LMS systems
• Develop, maintain, and improve business processes and procedures; ensure effective system integration, regulatory controls, and training programs
• Support change management initiatives, system upgrades, and retirements, ensuring business needs and data requirements are fully met
• Monitor system performance, data integrity, and readiness for audits or inspections, taking action to improve reliability and compliance
• Lead user communities and foster knowledge sharing through regular meetings and communications
• Promote and implement digital innovation in partnership with colleagues across Takeda, driving greater efficiency and predictability
• Be a champion for digitalization, data quality and out-of-the-box thinking in how we can digitalize and modernize practices related to Global Quality systems

Qualifications

• Innovative spirit and intellectual curiosity combined with a passion for improvement
• Deep understanding of pharmaceutical industry regulations and global quality standards
• High degree of empathy and understanding for others’ point of view and ability to humbly challenge the status quo
• Experience with electronic quality systems and digital technologies is highly desirable
• Strong analytical and problem-solving skills; able to identify process gaps and implement effective solutions
• Excellent communication and collaboration skills, with experience working across functions and cultures
• Ability to lead through change, influence stakeholders, and support strategic business initiatives
• A mindset open to embracing new digital solutions and innovative approaches
• Commitment to core values, including patient focus, trust, and business excellence

Skills

• Digital transformation
• Quality systems (DMS, LMS)
• Regulatory compliance
• Process improvement
• Change management
• Stakeholder management
• Data quality and analytics
• Cross-functional collaboration

Education

• Not specified

Additional Requirements

• Location: USA - MA - Lexington