Role Summary
As Director, Global Quality Systems (DMS & LMS), you will serve as the enterprise Business System Owner for Takeda’s Document Management System (DMS) and Learning Management System (LMS). You will drive the design, implementation, and deployment of the DMS & LMS electronic systems, navigating complex cross-functional challenges—balancing compliance, business needs, and technological innovation—while remaining hands-on to understand system configurations, investigate issues, and support end users when needed. You will lead digital quality modernization and foster scalable, future-ready digital solutions.
Responsibilities
- Lead the implementation, enhancement, and lifecycle management of enterprise DMS and LMS solutions, ensuring alignment with global standards, GxP requirements, and Takeda’s quality management framework
- Provide senior leadership for highly complex issues, acting as the primary escalation point for systemic problems, inspection/audit observations, and cross-functional decision making related to DMS and LMS
- Translate business needs into robust technical and process solutions, collaborating closely with IT, Quality, Manufacturing, R&D, and Commercial to design efficient, compliant workflows and integration
- Maintain a strong hands-on understanding of the systems, including configuration, data structures, user roles, and interfaces, enabling you to guide troubleshooting, support complex user issues, and validate technical proposals
- Define and govern business processes and procedures related to document and learning management, ensuring effective system integration, regulatory controls, training curricula, and data integrity
- Lead change at enterprise scale, leading change management initiatives, major system upgrades, and migrations/retirements, and ensuring that business needs, data requirements, and impact on users are fully addressed
- Establish and oversee governance forums and user communities, fostering knowledge sharing, user engagement, and continuous improvement through regular meetings, communications, and feedback loop
- Monitor and continuously improve system performance and inspection readiness, using metrics and analytics to proactively address risks, strengthen compliance, and enhance user experience
- Drive digital innovation and automation, partnering with internal and external experts to explore AI, advanced analytics, and other emerging technologies that can modernize quality practices and reduce manual effort
- Represent Global Quality Systems with senior stakeholders, aligning priorities, managing expectations, and influencing decisions that affect Takeda’s global quality and digital ecosystem
Qualifications
- A strategic, innovative mindset with the ability to shape and execute a long-term vision for global quality systems while delivering tangible, short-term improvements
- Extensive experience in the pharmaceutical or biotech industry, with deep knowledge of GxP regulations, global quality standards, and inspection expectations related to document and learning management
- Proven leadership in enterprise-level DMS and/or LMS ownership, including strategy, implementation, and ongoing governance
- Ability to operate at both strategic and hands-on levels—comfortable engaging with senior leaders on risk and investment decisions, and equally comfortable diving into system details, data issues, and complex user problems
- Strong analytical and problem-solving skills, capable of diagnosing process and system gaps, balancing compliance and efficiency, and implementing effective, scalable solutions
- Demonstrated success in leading through change in a complex, global environment—able to influence without authority, build consensus, and guide diverse stakeholders through digital and process transformation
- Excellent communication and collaboration skills, with experience working across functions, geographies, and cultures, and translating technical topics into clear business language
- A track record of promoting digitalization, data quality, and innovative thinking, ideally including AI, automation, and data-driven decision making in quality or GxP context
- Experience in a large, global pharma or biotech company; background from a top-20 global pharmaceutical organization is a strong plus
- Commitment to Takeda’s core values, including patient focus, trust, reputation, and business excellence, and a genuine passion for improving how quality is delivered through modern digital systems