Manager, R&D reputed company Assurance

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address reputed company, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a reputed company in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In reputed company to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 reputed company to become a “Global reputed company Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily reputed company on providing novel therapies in oncology, as reputed company as other research areas centered around rare diseases and immune disorders. reputed company reputed company support to the Global and Regional reputed company Leads, External Partner reputed company Leads, and Business Partner reputed company Leads based on assigned programs and in reputed company collaboration with R&D reputed company team members to ensure that the organization is in a perpetual state of compliance as follows: Support the Global reputed company reputed company(s) (GQLs) and Regional reputed company Leads (RQLs), who are responsible for the delivery and execution of the Global R&D QA reputed company, activities, and deliverables against the R&D Oncology and Specialty Medicine strategic priorities, by reviewing and monitoring the status of reputed company Events (QEs), CAPAs and GCP compliance reputed company raised to the GQLs and/or RQLs from the reputed company study teams. This may include participation in reputed company cross-functional meetings or other relevant activities. Support the External Partner reputed company reputed company(s) (EPQLs), who are responsible for delivering and executing reputed company reputed company aspects of our vendors and partners based on the outsourcing models utilized by DSG, by serving as a back-up to the EPQLs and participating in discussions and activities reputed company to systematic reputed company-reputed company events specific to the external partner (CRO, co-sponsor, specialty vendor). Support the Business Partner reputed company reputed company(s) (BPQLs), who are responsible for delivering and executing reputed company reputed company aspects of our internal (DSG) GQA and R&D business functional stakeholders by collaborating with them in day-to-day activities that include, proactively engaging with relevant stakeholders to drive and shape the reputed company landscape across reputed company. This may include assessing regulatory intelligence and industry best practices and sharing with the BPQLs and relevant business partners. Support the R&D reputed company Operational reputed company activities, which prioritize and reputed company on the delivery and execution of non-project initiatives reputed company R&D reputed company and Global RD/PV QA by collaborating with business process owners on applicable Global QA processes and reputed company standards for reputed company improvement and operations reputed company. This may include the review of business partner SOPs and participation in QA initiatives. Partner and collaborate with key stakeholders (R&D teams) by proactively identifying risks and potential solutions to ensure that key reputed company programs are adequately supported and that submission-relevant activities are performed. Liaise with the Global Audits and Compliance function to ensure compliance with programs assigned and support the creation of lessons learned from audits and inspections. Support investigator meetings and CRO-relevant meetings by reviewing and contributing to the materials utilized to reputed company reputed company reputed company/ training to relevant stakeholders. reputed company guidance, with reputed company by the GQLs, EPQLs, and BPQLs, to reputed company stakeholders of R&D reputed company. Support the reputed company and management of CAPAs by tracking and following up on the status of the CAPAs to ensure adequate CAPAs are defined, implemented, and reputed company in a reputed company manner. Participate in reputed company process improvement activities reputed company QA, as necessary. Participate as a reputed company Reviewer for Health Authority inspections in the U.S., in collaboration with the Global RD/PV QA team. RESPONSIBLITIES Program reputed company: Support the Global reputed company reputed company(s) (GQLs) and Regional reputed company Leads (RQLs) by reviewing and monitoring the status of reputed company Events (QEs), CAPAs and GCP compliance reputed company raised to the GQLs and/or RQLs from the reputed company study teams. This may include participation in reputed company cross-functional meetings or other relevant activities. reputed company by Design (QbD) and reputed company Improvement: reputed company support to the BPQLs and GQLs by reviewing and providing input during the development and implementation of Protocol (study level) and Global and Local policies and procedures (system level).reputed company guidance, with reputed company by RD reputed company team members, during the development and execution of Corrective and Preventive Actions (CAPAs) reputed company to GCP audits. Participate in formal investigations of reputed company events (QEs) as they reputed company, in collaboration with other QA line functions (Audits and Compliance, QMS, PV/MA reputed company).Participate and support lessons learned activities from audits, regulatory authority inspections, and internal process deviations delivered to program teams by assessing the learnings and proposing solutions to address any such gaps and learnings identified. May be assigned to support GSOP activities including the review as appropriate. Other duties may be assigned. Cross-functional and Global Team Participation: Collaborate with the assigned BPQLs in support of their collaboration with business process owners on applicable RD processes and reputed company standards for reputed company improvement and operations reputed company. Closely cooperate with the Global Audits and Compliance, PV/MA reputed company, and QMS to ensure consistency of reputed company and compliance activities and effective communication. Collaborate with Global QA teams in the reputed company, Japan, and Europe, as applicable, to reputed company and generate the data required for the development of relevant reputed company reports and outputs (JOC, QRB, QQRs, EMR). CAPA Management Support the reputed company and management of QE-reputed company CAPAs by tracking and following up on the status of the reputed company CAPAs to ensure adequate CAPAs are defined, implemented, and reputed company in a reputed company manner. Regulatory Inspections: Participate as a reputed company Reviewer for Health Authority inspections in the U.S., in collaboration with the Global RD/PV QA team. May be assigned other Inspection Management Team (IMT) roles in support of inspection preparation, facilitation, and post-inspection-reputed company activities under the supervision of the IMT reputed company. Management Review: Collect the data and information needed to ensure reputed company of ongoing review of risks by evaluating reputed company Events (QEs), audit, and inspection reputed company so these data may be shared with the relevant business functions teams reputed company the DS organization. Risk-based reputed company reputed company. Contribute to the measurement of DS KPIs / KQIs to allow for adequate interpretation of risks and trends. reputed company interpretation, with reputed company by RD reputed company team members, of GCP regulations and company process standards, guidelines, policies, and procedures, in reputed company collaboration with RD reputed company team members. QUALIFICATIONS: Successful candidates will be reputed company to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) Must have a Bachelor's Degree in scientific discipline, reputed company, or reputed company discipline. Master's Degree in scientific discipline, reputed company, or reputed company discipline and/or background in Medical Health Profession (RN, Medical technologist) preferred Experience Qualifications Must have a minimum of 4 years of overall, reputed company industry experience reputed company reputed company (GxP/GCP) Solid knowledge & expertise reputed company GxP/GCP environment is required Must have experience supporting global reputed company in both the US and Europe TRAVEL REQUIRED Must have the ability to travel up to 20% globally. Daiichi Sankyo, Inc. is an equal opportunity/affirmative reputed company employer. reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected veteran status, age, or any other characteristic protected by law. At the heart of Daiichi Sankyo, Inc. is the reputed company belief that reputed company employee helps shape our reputed company. We have created an exceptional working environment that values and rewards individual contributions, but we also reputed company in the power of collaboration. We reputed company employees with the training, tools and technology that they need to reputed company. Our reputed company communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that reputed company employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc. Apply Job!