Director, Clinical Quality Assurance

Eisai US

. Design, deliver, and execute the North America Clinical Quality Assurance strategy .

Posted 10/23/2026full-timeUnited StatesLead💰 $195,000 - $256,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Clinical Quality Assurance, including GCP auditing, compliance with regulatory standards, and oversight of clinical operations. Proven ability to manage audits, facilitate inspections, and influence stakeholders while ensuring adherence to quality management systems.

Highest-signal resume keywords

GCP AuditingClinical Quality Assurance StrategyRegulatory ComplianceInspection ManagementData Integrity Controls

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchSite MonitoringStudy ManagementAnalytical SkillsReport WritingQuality Management System OversightTherapeutic Area KnowledgeAudit ExecutionProtocol TranslationGxP Systems Knowledge

Soft Skills

CollaborationInfluencing StakeholdersLeadership

Industry Keywords

Good Clinical PracticeEisai SOPsUS Regulatory StandardsEU Regulatory StandardsInternational Regulatory GuidelinesClinical TrialsComputer System Validation

About the role

Key responsibilities & impact

Design, deliver, and execute the North America Clinical Quality Assurance strategy
Conduct audits independently
Oversee and guide CQA audits of study sites, clinical vendors, clinical documents, and internal processes
Facilitate Sponsor health authority inspections of global clinical facilities and study sites
Oversee the Quality management system
Provide Good Clinical Practice oversight
Assure project, product, and program compliance with Eisai SOPs, policies, worldwide regulations, and guidelines
Provide skill-building interventions for CQA staff through cross-functional and external partnerships
Potentially manage people directly

Requirements

What you’ll need

Bachelor's degree in an associated functional discipline; advanced degree preferred
Minimum 12 years in clinical research, operations, or a related area
Prior experience in site monitoring and study management preferred
Strong knowledge of multiple therapeutic areas, such as neuroscience and oncology
Ability to translate key protocol objectives into auditable activities
5+ years of experience in GCP auditing
Substantial experience in inspection management
Substantial experience with US, EU, and international regulatory standards and guidelines for clinical trials
Ability to influence and collaborate with senior stakeholders while maintaining Quality's independence and authority
Technical and administrative capabilities to independently carry out routine, complex, and for-cause audits
Knowledge of data integrity controls and systems quality for clinical areas
Strong analytical and report writing skills
Knowledge of GxP systems, including computer system validation and associated regulations, recommended
Ability to travel approximately 15%

Benefits

Comp & perks

Eisai Inc. Annual Incentive Plan
Eisai Inc. Long Term Incentive Plan
Company employee benefit programs
Hybrid/remote work arrangement for candidates near an Eisai location
Remote work arrangement consisting of 2–4 days in office per month for candidates near an Eisai location