Sr. Specialist , Global Strategy & Operations, QA

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 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, 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

This position is responsible to support the implementation of the Global R&D PV QA organizational strategy. This position will proactively collaborate with other Global quality colleagues to drive the global QA vision and act as the US QA point person for Strategy & Operations. This position will support continuous process improvement initiatives, support the annual Global Quality Strategy Plan for R&D PV QA and track business objectives through partnership with the QA leadership team . Position is responsible for support at the global organizational level. This position has considerable latitude to make decisions without supervisor approval and solves problems while carrying out assigned tasks. Additionally, this position is responsible for upholding a strong commitment to confidentiality and routinely handles sensitive documents that may impact multiple organizational units or project teams. This position has advanced skills in technology systems, content creation, word processing software and data management software, and business emailing software as well as intermediate skills in database and research tools.

Responsibilities

• Strategy Operations activities include but not limited to: Responsible to drive the vision and implementation of Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and Operations. In collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and Operations, candidate is responsible to support the implementation of culture change initiatives, Global QA Transformation activities and project level oversight including end to end risk-based deployment in relation to GxP QA activities. Involve and attend the QA strategic meetings and provide support to create presentation materials including the Monthly Global RD/PV QA reports. Responsible for tracking and overseeing the implementation of QA strategic initiatives, from development through execution in collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and Operations while also providing consultation for improvements. Ensure coordination and alignment of key stakeholders to ensure oversight of short-term objectives and long-term QA strategy. Responsible to support functional teams within RD PV QA for Global QA strategy within Daiichi Sankyo Cross-functional Collaboration: Responsible to serve as a liaison to support the collaboration and communication between leaders within the organization to ensure seamless execution of projects and initiatives related to QA activities. Support continuous process improvement initiatives through partnership with stakeholders and QA functions. Responsible to support the onboarding process, development of onboarding materials and ensuring proper onboarding and training processes are in place for RD PV QA Support the oversight of projects, tracking progress, identifying risks, and ensuring timely completion.
• Contract Management support includes but not limited to: Draft, evaluate, negotiate and execute a wide variety of different contracts covering a range of transactions. Create and maintain relationships with internal stakeholders and legal while serving as the singular point of contact for matters concerning contracts. Maintain records for correspondence and documentation in relation to established contracts and those in progress. Communicate and present information to stakeholders about all contract-related matters. Monitor contracts and move forward with close-out, extension, or renewal as necessary. Collaborate with Global QA functions to solve any contract-related problems that may arise internally and with external parties. Ensure that all employees are in compliance with all contract requirements
• Support the Associate Director Global Strategy and Operations and Head Global Strategy and Operations i