Director, Clinical Quality Assurance - Hybrid/Remote

Eisai; Nutley (NJ); Hybrid; USD 195,000 - 256,000; Full time

Job summary

Eisai is seeking a Director of Clinical Quality Assurance in Nutley, NJ, to lead the NA CQA strategy, audit delivery, and inspection management. The role ensures GCP compliance across projects and SOP adherence, while guiding ongoing quality improvements and staff development.

The position requires extensive experience in GCP auditing and regulatory standards, with opportunities for leadership and travel. Remote work options include periodic in-office collaboration in Nutley/Exton as needed.

Qualifications

• Bachelor's degree in an associated functional discipline; advanced degree preferred.
• 5+ years of experience in GCP auditing.
• Substantial experience with US, EU, and international regulatory standards for clinical trials.
• Ability to influence and collaborate with senior stakeholders while maintaining Quality's independence.
• Travel approximately 15%.

Responsibilities

• Independently conduct audits.
• Oversee and guide CQA audits of study sites, vendors, documents, and internal processes.
• Facilitate regulatory health authority inspections of global facilities and sites.
• Provide skill-building interventions for CQA staff across partnerships.
• Potential for direct people management.

Skills

Auditing

Inspections

Regulatory knowledge

Stakeholder influence

Audit management

Travel 15%

Education

Bachelor's degree

Advanced degree preferred

Tools

Computer system validation

Job description

Eisai is seeking a Director of Clinical Quality Assurance in Nutley, NJ, to lead the NA CQA strategy, audit delivery, and inspection management. The role ensures GCP compliance across projects and SOP adherence, while guiding ongoing quality improvements and staff development.

The position requires extensive experience in GCP auditing and regulatory standards, with opportunities for leadership and travel. Remote work options include periodic in-office collaboration in Nutley/Exton as needed.