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 Sr Mgr, GxP Systems 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 a GxP Systems Quality Assurance framework, the role is to provide assurance to Eisai management that the controls they have implemented are being executed.Essential Functions
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:
Requirements
Knowledge & Experience
#LI – SC1
#LI – VF
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.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
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