Director, Clinical Quality Assurance — Lead Audits & Inspections

Eisai US; Harrisburg (Dauphin County); Ibrido; USD 195.000 - 256.000; Tempo pieno

Descrizione del lavoro

Eisai US is seeking a Director, Clinical Quality Assurance to lead the NA CQA strategy, including audit management and inspection oversight. The role ensures GMP/GCP compliance across projects and programs under Eisai SOPs and global guidelines.

The position requires strong regulatory knowledge, extensive GCP auditing experience, and the ability to work with senior stakeholders. Hybrid arrangement with some travel supports NA operations.

Competenze

• Bachelor's degree in an associated functional discipline, advanced degree preferred.
• 12 years minimum in clinical research/operations or related area; site monitoring & study management preferred.
• 5+ years of experience in GCP auditing.
• Extensive experience with US/EU/international regulatory standards for clinical trials.
• Ability to influence senior stakeholders and manage audits independently.

Mansioni

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

Conoscenze

GCP auditing

Audit management

Regulatory compliance

Quality systems

Stakeholder collaboration

Audits planning

Travel readiness

Formazione

Bachelor's degree in a related field

Descrizione del lavoro

Eisai US is seeking a Director, Clinical Quality Assurance to lead the NA CQA strategy, including audit management and inspection oversight. The role ensures GMP/GCP compliance across projects and programs under Eisai SOPs and global guidelines.

The position requires strong regulatory knowledge, extensive GCP auditing experience, and the ability to work with senior stakeholders. Hybrid arrangement with some travel supports NA operations.