Sr. Specialist

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 in Global RD/PV QA on projects needing to be coordinated within Global QA, ensure that teams are adequately engaged to deliver as expected and escalate any delays to Head Global Strategy and Operations and / or Associate Director Global strategy and operations. Logistic planning and coordinating the QA Meeting which including the QA leadership meeting, Global QA meeting etc. Manage the QA shared point and ensure that information provided is accurate and reflects on going activities. Regularly check the site for accuracy, up to date information, and links as well as compile new content as required. Send periodic alerts to teams to ensure that shared point data is current and accurate
• In collaboration with the Head of Global Strategy Operations, Collate and produce accurate and timely reports as needed pertaining to QA activities
• Responsible to update organizational charts, team lists and track projects
• Provide Strategy Operations support for regulatory inspection related activities as required such as ensuring logistics for inspections including for the collection, storage and maintenance of inspection documentation as per DSI Internal control
• Works in close collaboration with QA leadership team to develop recommendation of process improvement projects/initiatives
• Distribute reports as necessary to the QA teams and ensure on time organization communication is cascaded to the teams for awareness.
• May support QA Administrative tasks across GxP functions as necessary

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)

• A High School Diploma is required.
• Associate's Degree strongly preferred

Experience Qualifications

• 4+ years of professional experience within the pharmaceutical industry working within Quality Assurance is required.
• Must have a broad understanding of Health Authority expectations in the areas of Pharmaceutical Development; working in a GxP regulated environment, pharmaceutical industry.
• Proven experience in training and curricula development experience, including oversight and administration of validated electronic systems such as Sharepoint, LMS, Trackwise Digital and other quality management systems.
• Strong interpersonal, communication, technical writing, negotiation and problem-solving skills with demonstrated ability to build collaborative relationships
• Strong project management skills
• Organizational awareness (e.g. inter-relationships of departments, business priorities), including experience working cross-functionally and in global teams.
• Candidate must be creative and show initiatives, be customer focused, results driven and be able to work effectively in a global environment.
• In depth knowledge and working experience with common computer software programs, i.e. MS Office Suite (Word, Excel, Access, Outlook, PowerPoint, Visio, MS Project)
• Physical Requirements: Shipping out large packages/boxes. Moving/arranging file folders in large quantities.

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.