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.
Represent or support Global Oncology Medical Affairs (GOMA) governance and operational transformational activities in close collaboration with functional, cross-functional, and/or regional stakeholders in the areas of: • Operational Transformational Initiatives • Audit Preparation and Inspection Readiness • Process and Governance Management
- Operational Transformational Initiatives:Support with understanding organizational operational transformational activities and contributing to the development or operational execution of a plan to addressHelp position the business as visible Global Process Leads in the organization for clinical and non-clinical activitiesSupport the organization with relevant operational transformational activities using practical applications of change management principles, methodologies, and toolsHelp prepare and/or facilitate discussions with stakeholders to understand key operational issues and gain alignment on a path forwardAssist with identifying cross-activity synergies or other opportunities to increase the overall effectiveness and efficiencies of day-to-day business activitiesHelp advance the availability and operational use of enterprise-wide educational tools and channels
- Audit Preparation and Inspection Readiness:In partnership with QA and Compliance, support the development and sustainability of an Audit Inspection Readiness Toolkit consisting of standardized educational activities, training materials, tools, and templates in the areas of:Guiding Principles TrainingBusiness Process Control ManagementAudit Preparation Inspection ManagementIndependently identify potential quality and compliance business issues and recommend appropriate remediationsExecute business process control activities for clinical and non-clinical activitiesSupport or lead business audit preparation, conduct, and closure activities such as tracking, ensuring review, and securing functional document requests or supporting the business to conduct root cause analysis and generating a Corrective and Preventive Action (CAPA)Help foster a culture of quality by sharing audit preparation and inspection readiness learnings, best practices, or toolkit with relevant stakeholders
- Process and Governance Management: Support the business to establish, maintain, and/or optimize global process and governance framework to meet overall business needs and minimize regulatory risk. Represent or support initiatives aimed to enhance functional presence and enterprise knowledge in the area of processes and/or governance. Identify and leverage existing tools, processes, or infrastructure to meet functional business needs and make a larger organizational impact. Help introduce industry leading process and governance solutions pragmatically to the business
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 required
- Master's Degree preferred
- ≥ 5 years' professional experience in a pharmaceutical company, Contract Research Organization (CRO), or equivalent experience required with Medical Affairs or Quality experience preferred
- Experience or ability to learn effective preparation, conduct, and closure for inspections and audits required
- Experience supporting the business or independently conducting root cause analysis and generating a Corrective and Preventive Action (CAPA) preferred
- Knowledge of relevant GxPs, regulatory guidelines, national codes, and industry standards preferred
- Knowledge and practical application of operational change management principles, methodologies, and tools preferred
Ability to travel up to 10% Standard/Home office based physical demands, minimal 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.