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 16,000 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
Lead the implementation of the quality strategy closely aligned with the business strategy within one or more Global Project Team(s) (GPT) within Oncology Development Franchises or Business Units. Provide strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head of R&D QA. Within assigned GPTs, facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and submission including all vendor managed business setups with the objective of achieving the highest data quality standards, full adherence to patient’s rights and well-being and in support of successful Health Authority inspections and approvals. Lead in a proactive and strategic way and through collaboration with other GxP Quality representatives, act as QA point person for all GxP matters for the Global Program Head and the Global Program Team. Provide operational QA leadership for the respective GPTs, including Quality Oversight for the Quality Plan execution, Health Authority Commitments, Critical Incidents including, respective escalation process and the CAPA Management Process for the respective business areas.
Responsibilities
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 in Life Sciences, Pharmacy or Medicines required
– Master’s Degree or other advanced degree preferred
Experience Qualifications
Travel
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.
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