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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.
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. 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
Under the direction of Head of QA GxP Audits, supports and ensures all assigned audits are managed, audit reports issued as per pre-defined timelines and mitigation and remediation activities related to the GxP audits are addressed throughout the audit cycle. Contributes to identifying which programs require prioritization for audits based on applied risk methodology. This position interacts across the GxPs and is pivotal in ensuring that the organization is in a perpetual state of compliance. May be tasked to work with integrity and compliance in assessing or addressing internal corporate audit needs for the organization in early and late strategy, development teams, Pharmacovigilance, Operational and Technical Services and others to ensure local and global conformance with regulatory requirements, good clinical practice, internal standards, and to provide pro-active integration of quality and process improvement. Accountable for ensuring lessons learned from audits and inspections are provided to stakeholders and throughout QA team to ensure end-to-end organizational awareness and continuous improvement. General awareness and understanding of systems and tools used for clinical trials and ability to assess processes and ensure its purpose (limited to validation activities).Deploys inspection readiness programs are in place and supports regulatory inspections in collaboration with other QA functions and stakeholders. In conjunction with QA Standards and Procedures, participates in continuous improvement initiatives stemming from lessons learned from audits and that may involve authoring procedural documents or enhancements.Ensures adequate audit strategy across boundaries and may be tasked to support audit activities within DS Group and/or affiliates. Accountable for engineering relevant training activities to support lessons learned and ensure regulatory understanding and impact stemming from audits and inspections. Ensure adequate issue escalation and risks are communicated to management and QA teams as aligned with QA Audit Planner and Risk Management. Ability to conduct activities independently and applies systemic approach and strategy to address any organizational risks identified through audits.
Responsibilities
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