Eisai US
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Director, Clinical Quality Assurance
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Eisai US 1 day ago Be among the first 25 applicants Join to apply for the
Director, Clinical Quality Assurance
role at
Eisai US At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisais human health care (hhc) mission. Were 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 Alzheimers 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 Eisais 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
Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. 5+ years of experience in GCP auditing. Substantial experience in inspection management. Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. Demonstrated ability to operate and influence decision-making processes Effective communication skills Successful track record of supervising employees and managing cross-cultural differences Technical and administrative capabilities to independently carry out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to Travel (approximately 15%)
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 :195,000-256,000
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:
Right To Work
E-Verify Participation
Seniority level
Seniority level
Not Applicable Employment type
Employment type
Full-time Job function
Job function
Quality Assurance Industries
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Director, Clinical Quality Assurance
role at
Eisai US 1 day ago Be among the first 25 applicants Join to apply for the
Director, Clinical Quality Assurance
role at
Eisai US At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisais human health care (hhc) mission. Were 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 Alzheimers 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 Eisais 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
Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. 5+ years of experience in GCP auditing. Substantial experience in inspection management. Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. Demonstrated ability to operate and influence decision-making processes Effective communication skills Successful track record of supervising employees and managing cross-cultural differences Technical and administrative capabilities to independently carry out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to Travel (approximately 15%)
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 :195,000-256,000
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:
Right To Work
E-Verify Participation
Seniority level
Seniority level
Not Applicable Employment type
Employment type
Full-time Job function
Job function
Quality Assurance Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Eisai US by 2x Get notified about new Director of Quality Assurance jobs in
Nutley, NJ . New York City Metropolitan Area 2 days ago Millburn, NJ $168,000.00-$312,000.00 3 weeks ago Associate Director, Quality Assurance - Third Party Quality Management - Hybrid
Rahway, NJ $126,500.00-$199,100.00 1 week ago Associate Director, Quality Assurance - Third Party Quality Management - Hybrid
Rahway, NJ $126,500.00-$199,100.00 1 week ago Associate Director, Quality Assurance - Third Party Quality Management - Hybrid
Rahway, NJ $126,500.00-$199,100.00 1 week ago Brooklyn, NY $100,000.00-$111,059.00 5 days ago Senior Manager - Call Center Quality Assurance
Executive Director, Head of Clinical Quality Assurance
Jersey City, NJ $252,000.00-$275,500.00 1 week ago Associate Director, Global Quality Assurance
New York, NY $140,000.00-$155,000.00 1 week ago Senior Director, Global Clinical Quality Assurance
Manager, Analytical Quality Assurance (AQA)
Chestnut Ridge, NY $95,000.00-$125,000.00 2 months ago Food Safety & Quality Assurance Director- Woodstock Farms
Head of Lab Solutions Manufacturing Quality
Tarrytown, NY $240,000.00-$360,000.00 2 days ago Basking Ridge, NJ $206,025.00-$343,375.00 2 weeks ago Director of System Clinical Quality Performance - West Orange, NJ
West Orange, NJ $133,924.00-$189,167.00 1 week ago Director of Government Contracts & Quality Assurance
New York, NY $90,000.00-$100,000.00 1 month ago Food Safety & Quality Assurance Director- Woodstock Farms
Director (OBH), Behavioral Health Quality Assurance
New York, NY $135,000.00-$200,000.00 2 weeks ago Sr. Director, Product Management, Developer Experience - Quality Assurance
Yonkers, NY $125,000.00-$130,000.00 2 days ago Quality Clinical Abstractor Manager- West Orange, NJ
West Orange, NJ $91,218.00-$123,263.00 1 week ago Director of Culinary & Inventory Operations
New York, NY $110,000.00-$125,000.00 1 week ago Director, Managed Care Contract Quality Analytics - Remote
Manhattan, NY $75,971.00-$100,958.00 4 weeks ago Basking Ridge, NJ $206,025.00-$343,375.00 2 weeks ago Bronx, NY $100,000.00-$120,000.00 1 day ago Bronx, NY $250,000.00-$275,000.00 3 months ago Brooklyn, NY $95,637.61-$114,272.00 6 days ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr