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 Clinical Quality Assurance Professional (QAP) position is responsible for design, delivery and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. EU Directives, US FDA, PMDA, ICH, and National regulations).
In the current times, drug development is going through a significant transformation with digitalization, utilization of big data and predictive analytics to revamp innovation in medicine. Clinical Quality Assurance at Eisai is an independent organization driving end-to-end quality in the R and D organization. This role is responsible for leading the digital transformation to enhance current quality oversight capabilities and knowledge within CQA and Eisai. This is a high visibility position with great impact potential.
Essential Functions
Requirements
Remote Work Arrangement :
Candidates near Eisai's NJ / PA locations will be preferred. For candidates near an Eisai location, the Remote Work Arrangement will consist of 2-4 days in office (Nutley / Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities.
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Eisai Salary Transparency Language :
The base salary range for the Senior Director, Clinical Quality Assurance - Remote-Based is from : 236,900-310,900
Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https : / / us.eisai.com / careers-at-eisai / benefits .
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
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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Director Quality Assurance • Nutley, NJ, United States