Director, Clinical Quality Assurance

Director, Clinical Quality Assurance

The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH).

• 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.

• 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%).
• Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2‑4 days in office (Nutley/Exton) per month and 1‑2 audits quarterly; remote audits are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities.

The base salary range for the Director, Clinical Quality Assurance is from: ,000. Under current guidelines, this position is eligible to participate in Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit

Certain other benefits may be available for this position; please discuss any questions with your recruiter.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

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