Eisai US · 12 hours ago
Director, Clinical Quality Assurance
Cary, NC
Full-time
Onsite
Director/Executive
$195K/yr - $256K/yr
12+ years expEisai US is a growing pharmaceutical company focused on neurology and oncology, dedicated to improving healthcare for patients and their families. The Director of Clinical Quality Assurance will be responsible for designing and executing the North America Clinical Quality Assurance strategy, ensuring compliance with Good Clinical Practice and overseeing audits and inspections.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Independently conduct audits
Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits
Facilitate Sponsor health authority inspections of global clinical facilities and study sites
Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs
Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies
May be responsible for direct people management including goal setting, performance management, development, and engagement
Qualification
Required
Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area
5+ years of experience in GCP auditing
Substantial experience in inspection management
Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials
Demonstrated ability to operate and influence decision-making processes
Effective communication skills
Successful track record of supervising employees and managing cross-cultural differences
Technical and administrative capabilities to independently carry out routine, complex and for-cause audits
Knowledge of data integrity controls and systems quality for clinical area
Strong analytical skills and report writing skills
Experience with GxP systems including computer system validation and associated regulations, recommended
Ability to Travel (approximately 20%)
Preferred
Candidates near Eisai's NJ/PA location will be preferred
Benefits
Eisai Inc. Annual Incentive Plan
Eisai Inc. Long Term Incentive Plan
Company employee benefit programs
Company
Eisai US
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. It is a sub-organization of Eisai.
1001-5000 employees
H1B Sponsorship
Eisai US has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (21)
2023 (12)
2022 (41)
2021 (14)
2020 (22)
Funding
Current Stage
Late StageLeadership Team
Tricia Brooks
VP and Head of Office, Government Affairs & Policy
Recent News
2025-12-09
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