Director, Clinical Quality Assurance

Eisai US

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

Posted 10/21/2026full-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, inspection management, and compliance with regulatory standards. Proven ability to lead audits, manage quality systems, and influence stakeholders while ensuring adherence to Eisai SOPs and global guidelines.

Highest-signal resume keywords

GCP AuditingInspection ManagementClinical Quality Assurance StrategyRegulatory ComplianceData Integrity Controls

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchAudit ManagementRegulatory StandardsAnalytical SkillsReport WritingStudy ManagementProtocol TranslationGxP Systems KnowledgeComputer System ValidationTherapeutic Area Knowledge

Soft Skills

CollaborationInfluencing StakeholdersLeadership

Industry Keywords

Good Clinical PracticeClinical TrialsEisai SOPsUS RegulationsEU RegulationsInternational GuidelinesNeuroscienceOncologyQuality Management SystemCross-Functional Partnerships

About the role

Key responsibilities & impact

Design, deliver, and execute the North America Clinical Quality Assurance strategy
Lead audit and inspection management and oversee the Quality management system
Provide Good Clinical Practice oversight
Assure compliance of projects, products, and programs with Eisai SOPs, policies, worldwide regulations, and guidelines
Independently conduct audits
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
Provide skill-building interventions for CQA staff through cross-functional and external partnerships
Potentially manage people directly
Attend inspections or critical inspection management activities in Nutley when required

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
5+ years of experience in GCP auditing
Prior experience in site monitoring and study management preferred
Strong knowledge of multiple therapeutic areas, including neuroscience and oncology
Ability to translate key protocol objectives into auditable activities
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 conduct 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, computer system validation, and associated regulations recommended
Ability to travel approximately 15%
Candidates near Eisai's NJ/PA location preferred
Eisai Inc. participates in E-Verify; employment eligibility is verified for new hires in the United States

Benefits

Comp & perks

Eisai Inc. Annual Incentive Plan
Eisai Inc. Long Term Incentive Plan
Company employee benefit programs
Remote Work Arrangement for candidates near an Eisai location, consisting of 2–4 days in office per month
Remote audits
Potential direct people management opportunity