Associate Director, Clinical Quality Assurance at Eisai

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 works within the Global Clinical Quality team to conduct GCP compliance activities at Eisai, at our CROs and Investigator Sites, and leading GCP audits and inspection readiness. This position is responsible for ensuring high quality execution of clinical trials from first in human through commercial marketing authorization of clinical trials. The position will manage cross functional relationships with internal and external stakeholders and be the Lead Quality Assurance representative to clinical teams on assigned trials. 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, Vendor Audits, GCP Document Audits (Clinical Study Reports and Trial Master Files), internal Process Audits and support 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

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

· Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials

· Knowledge of data integrity controls and systems quality for clinical area

· 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%)

Onsite at Nutley- at least 2 days working from the office

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Eisai Salary Transparency Language:

The base salary range for the Associate Director, Clinical Quality Assurance is from :158,900-208,500

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.

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