Director, Quality Master Data Management

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary

The Director, Quality Master Data Management (QMDM) reports to the Senior Director, Global QMS / eQMS and oversees multiple levels of direct reports (Associate Director, Manager, Analyst) across the global QMS function located in EU, JP/APAC and Americas. This individual is a member of the global quality RD/PV QA QMS extended leadership team and Global RDPV QA extended leadership team. This position is accountable to establish (Design /Build / Maintain) Master Data Management capabilities to support the needs of global QMS / eQMS systems. In doing so they support the drive for harmonization and standardization of global, enterprise level quality management IT systems to Support Global Quality Assurance (GQA) Global R&D, CSPV and Medical Affairs. This role collaborates with all levels of the organizations. Maintain knowledge with current industry trends, Health Authority expectations and influence standards accordingly to incorporate into business processes. The role will manage global QMS resources in an efficient and effective manner including, but not limited to oversight of defined work products, coaching and mentoring of global team, performance management and contributing to organizational efficiencies.

Responsibilities

- Customer Focus: Create an environment that fosters diversity of thoughts, inclusivity and one that adheres to the principals set forth in Our One DS Culture (Be Inclusive Embrace Diversity; Collaborate Trust: Develop Grow)o Help Support Enable Development of best-in-class Quality Master data structure for Daiichi Sankyo business functions across the GxPs.o Ensure process alignment and collaboration of Master data Vendor Quality Mgt QMS related actions with other functions whenever needed.
- Oversight: Establish (Design / Build / Maintain) Master Data Management (MDM) capabilities (process/procedure /IT solutions) to support the needs of global QMS systems. Partner with DX/IT, RDx , Procurement, HR and others as necessary in building model to support all QMS systems (such as eQMS and ALTOS LMS).o Core Master Data sets to be established to support global quality include Vendor Master and Product Master. These data sets cover the Pharmaceutical Lifecycle to support eMQS from Development through Commercialization.
- Leadership/team management: Foster a quality culture and a Quality Mindset where a robust Quality Management System is jointly maintained with all business process owners, driven by continual improvement and consistently applied across business functions (RD, CSPV, MA, Compliance) and fully in line with worldwide health authority requirements. Drive collaboration, alignment and awareness of Master Data needs across Global Quality and Non-RD Functions (DX/IT, CSPV, Legal, Med Affairs, Drug Supply, Compliance) who are either direct or downstream users/consumers of the related QMS Systemso Create a high-performing team environment and a cohesive culture driven by values of integrity, respect, and culture of speak upo Lead and hold others accountable to performance, talent, and development objectiveso Create an environment that thrives on innovation, proactive quality and is disciplined to efficiently execute against pre-defined deliverables. Drive employee engagement, mentoring, coaching and performance management. Exhibit servant leadership while driving results.
- External Engagement. Continuously review compliance metrics trends from regulators/ industry experts and align to develop the Quality Master Data Management road map(s) to meet changing regulatory and business needs. Lead as assigned, remediations and risk management to assure the organization’s quality management system design is robust and ensure knowledge transfer and continuous process improvement in collaboration with other QA functions.
- Strategy: Partner with Global DX/IT, RD Global procurement, Alliance Management, Supply Chain, Compliance and other business functions to create a strategic plan for Quality Vendor Master aligned to overall Vendor Management needs for CRO /ARO /CDx partners and other vendor categories. Partner with Global DX/IT, RD Excellence Supply Chain and other business functions to create a strategic plan for Quality Product Master aligned to Global Quality needs across the Pharmaceutical Lifecycle. Support creation and maintenance of a strategic road map, and multi-generational planning (MGP) for Quality Master Data as it related to leading an efficient and effective global quality organization. Support the global quality annual objectives, and strategic initiatives to deliver against the business plan as it related to QMDM

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

- Bachelor's Degree Computer Science, Life Science, Engineering, Business Administration, or a related discipline or equivalent work experience required

Experience Qualifications

- Minimum twelve years of experience within life sciences supporting GXP global business process/systems serving cross-functional stakeholders is required
- Experience building Master Data Management (MDM) process for global regulated matrix organization required
- Global experience serving as the liaison between Business & IT, translating business needs into technical solutions and technical jargon into business speak is required. Broad understanding of Master Data needs for business across all functions (QA, R&D, Procurement, Compliance) required
- Strong expertise in process engineering, continuous improvement, change management, and evolving the capabilities of an organization required.
- Strong Data analyst experience required

Travel

Ability to travel up to 10% International travel to DS locations

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.