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, GCP Quality Assurance oversees GCP activities at Eisai, our CROs and Investigator Sites, leads GCP audits and inspection readiness. The successful hire will ensure high quality execution of clinical trials from first in human through launch and beyond. This person will manage cross functional relationships with internal and external stakeholders and be the primary Quality Assurance representative to clinical teams. This is a high visibility position with great impact potential.
Proactively provide GCP QA support for clinical development activities to protect patient safety & wellbeing, maintain data integrity, and support operational excellence
Independently conduct Clinical Investigator Site Audits, GCP Document Audits (Clinical Study Reports and Trial Master Filesnd support Vendor/System audits
Author and manage Audit Plans and Audit reports
Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to clinical teams
Support health authority inspections
Review and provide input to clinical documentation (e.g. protocols, study reports, IBs, ICFs, etc.)
Compile and analyze audit metrics to communicate trends to business groups
Conduct GCP training sessions for business groups
Bachelor's degree required with minimum 5-8 years relevant GCP experience including 2-5 years of GCP auditing experience
Technical and administrative capabilities to independently carry out routine and complex audits
Experience of inspection management
Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials
Strong analytical skills and report writing skills
Ability to demonstrate tact as a representative of the CQA Department
Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently
Ability to Travel (approximately 25%). Primarily within North America.
Flexible job location
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: