Associate Director, Clinical Quality Assurance (Remote Opportunity) at Eisai in Woodcliff Lake, New Jersey

Job Description:

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.

Job Summary

The Associate Director, 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 commercial marketing authorization of clinical trials. This person will manage cross functional relationships with internal and external stakeholders and be the Lead Quality Assurance representative to clinical teams. This is a high visibility position with great impact potential.

Responsibilities

• 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 Files), internal Process Audits and 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


• Manage health authority inspection preparation activities and provide leadership and oversight during 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


• Manage direct reports (if applicable)

Requirements

• Bachelor's degree in associated functional discipline, advanced degree preferred


• Preferably 8+ years' experience in Clinical research/ operations/data management or related area. Minimum of 3-6 years of Clinical Quality Assurance auditing


• Technical and administrative capabilities to independently carry out routine, complex and for-cause audits


• Experience of inspection management


• Experience with supervising direct reports preferred


• 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%)


• Location: Woodcliff Lake, NJ or remote. Candidate should be willing to work at Woodcliff Lake site 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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