Associate Director, QA Strategy and Operations in Basking Ridge, NJ at DSI

Date Posted: 4/7/2021

Job Snapshot

Job Description

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. 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.

Job Summary:

This position is responsible to support strategic leadership of QA initiatives within QA and will have the primary responsibility to collaborate with, and support the head of Global QA strategy and operations. In this position, the incumbent will take on organizational responsibilities relevant to drafting global communications for QA, QA projects as assigned, ensuring onboarding of N-3 leaders directly reporting to the VP of Quality, and in close collaboration with the QA Training and Documentation management team. This position will take direction from global strategy and operational QA leader, however is also accountable to the VP of quality. The incumbent is expected to understand and apply rigor, focus and dedication with respect to the complexity of the Global organization. This position has considerable latitude to make decisions without supervisor approval and solves problems while carrying out assigned duties. Additionally, this position is responsible for upholding a strong commitment to confidentiality and routinely handles sensitive documents that may impact multiple Global organizational units or Global project teams. The incumbent may be tasked under the direction of the Global Strategy and Operations Head, to draft presentation for VP of QA, assess organizational transformation and its effectiveness and support large conferences and meetings. The incumbent must have excellent communication, oral and written skills. The incumbent must have understanding of state of the art technology systems necessary to complete tasks and allow decision making.
Responsibilities:
  • Support Head, Global strategy and operations on projects needing to be coordinated with both DSI QA and Global QA, ensure that teams are adequately engaged to deliver as expected and escalate any delays to Head of Group and / or Head Global strategy and operations.
  • Supports Head Global Strategy and Operations for Global RD/PV/MA QA relevant activities including QQR, monthly quality report, team building and management review.
  • Involve and attend the Global QA relevant meeting and create the draft of presentation, meeting agenda and meeting minutes.
  • Involve and attend the Global RD/PV/MA QA strategic meeting and create the draft of presentation, meeting agenda and meeting minutes.
  • May be delegated for logistic planning and coordinating the QA Meeting which including the QA leadership meeting, Global QA meeting etc.
  • Support Head, Global Strategy and Operations to track the objective and the mid-term plan in Global QA to ensure Global QA activities globally.
  • Support Head, Global Strategy and Operations to draft the Global RD/PV/MA QA strategy operation plan with Head, Global QA function to ensure Global QA activities globally.
    Support Operational activities:
  • 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 Head, Global QA Strategy and Operations, Collate and produce accurate and timely reports as needed pertaining to Global QA activities
  • In collaboration with Executive admin, ensure QA org charts, team lists, projects assigned to individuals are current and up to date
  • Support regulatory inspection related activities as required
  • Support Head, Global strategy and operations to develop and plan the Global QA governance, communication strategies and manage the communication activities;
  • Distribute reports as necessary to the Global QA teams and ensure on time organization communication is cascaded to the teams for awareness.
  • Creates and proofs packets of information; develops documents and materials for meetings and a wide array of audiences
  • Edits and produces advanced internal and external communications; acts on behalf of an executive for certain decisions or activities (e.g., e-mails)
  • Create the weekly QA communication e-mail
  • Administrative support includes but not limited to: Responsible for travel, Financial Administration as needed (e.g. tracking of expenses for travel and office space), meeting arrangements for Head of Group and other associates as applicable. Handling of confidential documents (reorganization, talent profile, Financial Budget)
  • Manage Calendar for DSI QA Head and Head, Global Strategy and Operations and ensure an organized approach
  • Onboarding support: Coordinate QA on boarding business training with New Hire and ensure New Hire has a sufficient access to the system and information to do that work.
  • Review the QA onboarding business slides edits and updates as needed

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

    Education/Experience:
  • Bachelor's Degree in scientific discipline or higher in, health care, or related discipline; and/or background in Medical Health Profession required
  • 7 or More Years pharmaceutical experience in Project management and Operational support role and relevant additional career training required
  • 1 or More Years Broad understanding of Health Authority expectations in the areas of Pharma Development; preferably working in a GxP regulated environment, pharmaceutical industry required
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.