Director, Clinical Quality Assurance

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Director, Clinical Quality Assurance

Apply remote type Hybrid Work Arrangement locations New Jersey, Nutley New Jersey, Newark New York, Brooklyn time type Full time posted on Posted 30+ Days Ago job requisition id R3713

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.

Director, Clinical Quality Assurance

The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, 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. US, EU Directives, US FDA, PMDA, ICH).

Essential Functions

• Independently conduct audits
• Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits
• Facilitate Sponsor health authority inspections of global clinical facilities and study sites
• Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies / procedures across clinical quality programs
• Direct skill-building interventions for CQA staff through cross-functional / external partnerships to reskill / upskill and adapt the workforce to evolving technologies.
• May be responsible for direct people management including goal setting, performance management, development, and engagement.

Requirements

This role is hybrid and requires at least 2 days per week working onsite in our Nutley, NJ office.

Eisai Salary Transparency Language :

The base salary range for the Director, Clinical Quality Assurance is from : 195,000-256,000Under 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 .

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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E-Verify Participation

At Eisai Inc., human health care ( hhc ) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary ofTokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.

Eisai is a fully integrated pharmaceutical business that operates in two global business groups : oncology and neurology (dementia-related diseases and neurodegenerative diseases). Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us atwww.eisai.com / US and follow us on Twitter and .

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