Director, Clinical Quality Assurance — Remote/Hybrid Audits

Eisai US; Nutley (NJ); Hybride; USD 195 000 - 256 000; Plein temps

Résumé du poste

Eisai US is seeking a Director, Clinical Quality Assurance in Nutley, NJ, to lead NA CQA strategy, audits, and inspection management across global programs. The role ensures GCP compliance and alignment with Eisai SOPs and regulatory guidelines, working with senior stakeholders to uphold quality across clinical trials.

The ideal candidate has extensive GCP auditing experience, deep knowledge of GxP systems, and the ability to travel ~15% while guiding cross-functional teams and potentially

Qualifications

• Bachelor’s degree in an associated functional discipline; advanced degree preferred.
• Experience with GCP auditing and inspections.
• Strong knowledge of US/EU/international regulatory standards for clinical trials.
• Ability to travel ~15% and manage cross-functional partnerships.

Responsabilités

• Independently conduct audits across study sites, vendors, documents, and internal processes.
• Oversee and guide CQA audits and coordinate sponsor inspections.
• Support health authority inspections of global facilities and sites.
• Provide skill-building for CQA staff and contribute to workforce development.

Connaissances

GCP auditing

Inspection management

Regulatory standards

GxP systems

Travel

Leadership/people management

Formation

Bachelor’s degree in a related field

Description du poste

Eisai US is seeking a Director, Clinical Quality Assurance in Nutley, NJ, to lead NA CQA strategy, audits, and inspection management across global programs. The role ensures GCP compliance and alignment with Eisai SOPs and regulatory guidelines, working with senior stakeholders to uphold quality across clinical trials.

The ideal candidate has extensive GCP auditing experience, deep knowledge of GxP systems, and the ability to travel ~15% while guiding cross-functional teams and potentially