Senior Manager, IT Quality Assurance
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We?re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Senior Manager, IT Quality Assurance is responsible to help ensure Eisai is choosing, deploying and supporting computing platforms and solutions in compliance with applicable global regulations and in accordance with Eisai standards and senior management intentions. Through an IT Quality Assurance framework, the role is to provide assurance to Eisai management that the controls they have implemented are being executed.
The Senior Manager is responsible for providing guidance on GxP and validation process improvements to increase efficiency and effectiveness and reduce cycle times and documentation overhead while maintaining the intended level of controls. The Senior Manager is responsible for supporting quality awareness efforts to ensure quality principles are disseminated throughout the IT organization and affected user communities.
Quality Assurance Framework:
Responsible as assigned, to design and deploy Quality Assurance (QA) processes, procedures, and systems (including QMS) to assure compliance with applicable GxP regulations and company standards.
Scope includes the following areas:
IT System Implementation and Maintenance:
Internal and External Auditing and Compliance Management:
Engagement with Regulatory Agencies:
Training and Education:
Knowledge & Experience
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
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