Senior Director, Global QMS/eQMS

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 Senior Director, Global QMS/eQMS reports to the Executive Director, Quality Management System RD/PV QA and oversees multiple levels of direct reports (Director, Associate Director, Manager) 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 leadership team and the Global RDPV QA extended leadership team. The position may also serve as a delegate to represent QMS in other cross-functional leadership teams such as the Global IT governance board, Dx organization, and R&D. This position is accountable to drive harmonization and standardization of global, enterprise-level quality management IT systems ( including but not limited to eQMS TrackWise) to Support Global Quality Assurance (GQA) Global R&D, CSPV and Medical Affairs. This role collaborates with all levels of the organization, including GMP QA and QA teams across regions. Maintain knowledge with current industry trends, and 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, and inclusivity and one that adheres to the principles set forth in Our One DS Culture (Be Inclusive Embrace Diversity; Collaborate Trust: Develop Grow)o Build, Support Enable the Development of best-in-class Quality Management systems for Daiichi Sankyo business functions across the GxPs. Proactively ensure that all functions consistently operate in a state of compliance. Define the process for alignment and collaboration of QMS related actions with other functions whenever needed.

-Oversight:

-Establish (Design / Build /Maintain) globally deployed IT solution(s) related to areas of responsibility to include but not limited to:-CAPA-Management Reviews-Non-conformances-Quality Systems Review, Quality Planning, and Quality Objectives-Analytics and Quality Scorecards-Change Control- in collaboration with GMP QA-Product Recall - in collaboration with GMP QA-Vendor Quality-Establish (Design / Build / Maintain) Master Data Management 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).

-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) and fully in line with worldwide health authority requirements Drive collaboration, alignment, and awareness 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 Systems Maintain a seamless and effective partnership with DX/IT throughout the entire System Development Lifecycle of QMS systems via the establishment common Enterprise governance model for all QMS systems( eQMS, ALTOS LMS, Veeva Vault QDocs) across SDLC including the process for continuous improvements/ enhancements, via regular cadence of system improvements/upgrades (i.e., monthly, quarterly and yearly) .o Serve as Global Business Owner (BO) for eQMS and Quality Doc Veeva Vault (QDocs) Create a high-performing team environment and a cohesive culture driven by values of integrity, respect, and culture of speak up Lead and hold others accountable to performance, talent, and development objectives Create an environment that thrives on innovation, and 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 develop the eQMS road map to meet changing regulatory and business needs. Lead 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 the RD Excellence (RDx) function to develop strategic planning for QMS systems, including interfaces with RD systems to support and drive standardization of Quality Systems to become more effective and efficiently aligned with RDx initiatives. Support creation and maintenance of a strategic road map, and multi-generational planning (MGP) for eQMS including metrics, dashboard, and project management methodologies as it related to leading an efficient and effective organization. Support the global quality annual objectives, and strategic initiatives to deliver against the business plan.

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

-5 or More Years Previous experience at Director level (or above) leading a QMS or related organization and demonstrated track record of successful results required preferred

-Minimum twelve years of experience within life sciences supporting the delivery of GXP validated global business systems serving cross-functional stakeholders is required required

-Minimum five years managing enterprise-level QMS applications such as Trackwise (preferred) application as a single or multiple business systems owner with users in multiple geographical locations and functions required required

-Global experience serving as the liaison between Business & IT, translating business needs into technical solutions and technical jargon into business speak is required preferred

-Experience managing global IT systems either on the IT or Business side is required preferred

-Strong expertise in process engineering, continuous improvement, change management, and evolving the capabilities of an organization required preferred

Travel

Ability to travel up to 10% International travel across Daiichi Sankyo 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.