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Manager, QA Strategy & Operations

Job Description
Join a Legacy of Innovation 110 Years and Counting!

With over 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 hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

Position is responsible for supports of strategic leadership to manage DSI QA Functional activities and Global QA activities. This position is expected to contribute to build the QA strategy to the Global QA and DSI QA organization within Daiichi Sankyo Group. This position will be integral to ensuring the smooth operation of Global QA and DSI QA management and working with Director QA Strategy Operations in organizing and reporting QA activities.

Responsibilities include QA project management duties (managing scope, time, cost and quality) and ensuring that key project milestones are defined and met and that appropriate communications occur with stakeholders across multiple regions. This position performs support tasks DSI QA Head and DSI QA Leadership members as well as Director QA Strategy and Operations. This position also performs support tasks in which incumbents are expected to understand and apply knowledge of the complexity of the Global organization. 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 Global organizational units or Global project teams. This position must have excellent verbal and written communication skills and be comfortable interacting with many different functional groups and leaders. This position has advanced skills in technology systems, including word processing software and data management software, and business emailing software as well as intermediate skills in database and research tools.

Responsibilities:

Support the Director QA 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 Director strategy and operations.

  • Supports the Director QA Strategy and Operations for Global RD/PV QA relevant activities including QQR, 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 QA strategic meeting and assist in the coordination of key deliverables including but not limited to: senior management presentations, Project updates and timelines, meeting agendas and minutes.
  • Prepare and manage the Monthly DSI QA reports with DSI QA Leadership member.
  • May be delegated for logistic planning and coordinating the QA Meeting which including the QA leadership meeting, Global QA meeting etc. 40 Page 2 of 3 • Proactively anticipate issues, challenges assumptions, and identifies contingencies or opportunities to circumvent potential delays. Follow-up on assignments and report progress to team.

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 the Director 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 such as organizing CAPA coordination teams, ensuring logistics for inspections, ensuring team list for QA pertinent to inspections are maintained including, training, CVs, JDs
  • Collect, store and maintain all auditable documentation as per DSI Internal control 30 3.
  • Support the Director QA strategy and operations to develop and plan the Global QA communication strategies and manage the communication activities;
  • Assist to develop a good understanding of the DSI QA budget and resource requirements.
  • 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 QA Connection 25 4 • Manage business onboarding program: maintain effective business onboarding training with New Hire and ensure New Hire has successful assimilation into their new role.

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

Education/Experience:

  • Required B.S. degree in scientific discipline or higher in, health care, or related discipline; and/or background in Medical Health Profession
  • Minimum 3 years pharmaceutical experience in Project management and Operational support role and relevant additional career training
  • Clinical R&D and Oncology experience required
  • Broad understanding of Health Authority expectations in the areas of Pharma Development; preferably working in a GxP regulated environment, pharmaceutical industry.
  • Training and curricula development experience desirable, including oversight and administration of validated electronic systems such as LMS or other quality management systems.
  • Strong interpersonal, communication, negotiation and problem-solving skills.
  • Organizational awareness (e.g. inter-relationships of departments, business priorities), including experience working cross-functionally, Cross cultural and in global teams.
  • In depth knowledge and working experience with common computer software programs, i.e. MS Office Suite (Word, Excel, Access, Outlook, PowerPoint, Visio, MS Project)
  • Effective planning and execution of operational activities needed in QA
  • Accurate and timely overview on project
  • Accurate and up-to-date share point page for QA
  • Adequate collaboration with HR and effective support of the recruitment process
  • Efficient travel coordination

Ability to travel up to 5%

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.

Manager, QA Strategy & Operations

Bernards, NJ
Full Time

Published on 11/14/2019