Takeda · 19 hours ago
Director, Global Quality Systems (DMS & LMS)
Takeda is a patient-focused company dedicated to transforming patient care through innovative pharmaceuticals and support programs. The Director, Global Quality Systems will be responsible for leading the design, implementation, and management of the Document Management System and Learning Management System while ensuring compliance and driving digital innovation within the organization.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
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 integrations
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 loops
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
Qualification
Required
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 contexts
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
Benefits
U.S. based employees may be eligible for short-term and/ or long-term incentives.
U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
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
Recent News
2026-01-09
2026-01-08
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