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 Associate Director, GCP Quality Assurance Systems & Data Integrity, will oversee quality oversight activities of Clinical trial Systems used by Eisai, Vendors & CROs and lead associated audits and inspection management. This person will manage cross-functional relationships with internal and external stakeholders and be the Lead Quality Assurance representative to IT and associated vendor management. This is a high visibility position with great impact potential.
Lead the conduct of internal clinical System/Process audits and Data Integrity & Access Governance (DIAG) audits as needed.
Lead the conduct of clinical vendor audits of CROs, laboratories, and other providers to clinical trials by conducting remote audits or on-site audits (as deemed necessary) in the Americas, following company procedures and practices, to verify data integrity, GCP compliance with ICH guidelines and government regulations/guidance.
Support health authority inspections and preparation activities related to IT aspects
Compile and analyze audit metrics to communicate trends to business group
Bachelor’s degree in associated functional disciplines including IT, Data Sciences, Pharmaceutical Science and others
8+ years of pharmaceutical company experience preferably in Clinical data management, Clinical Systems or related area.
Minimum of 3-6 years of Quality Assurance auditing experience with at least 2 years conducting Systems and clinical vendor audits
Experience with inspection management including leading inspection strategy
Knowledge of general GCP, clinical trial methodology, and specific knowledge of applicable regulations/guidance (including 21 CFR Part 11) and ICH Guidelines related to clinical computer systems
Clinical systems orientation with familiarity of emerging technologies such as cloud computing, mobility, and big data and its applicability to clinical research
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 20%)
Location: Woodcliff Lake, NJ (WCL) or remote. For remote: seeking candidates that are within driving distance to WCL. Candidate should be willing to work at WCL on as needed basis and on short notice for Health Authority inspections.
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.
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