Director, Clinical Quality Assurance

Eisai • Harrisburg, PA

2d • $195,000 - $256,000 • Remote

About The Position

The Director, Clinical Quality Assurance is responsible for designing, delivering, and executing the North America Clinical Quality Assurance strategy, including audit and inspection management and oversight of the Quality management system. The role provides Good Clinical Practice (GCP) oversight and assures that projects, products, and programs comply with Eisai’s Standard Operating Procedures, policies, and applicable worldwide regulations and guidelines, including US, EU, FDA, PMDA, and ICH requirements. The position may include direct people management.

Candidates near Eisai’s NJ/PA location are preferred. For candidates near an Eisai location, the remote work arrangement consists of 2–4 days in the 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 inspections or critical inspection management activities. Travel is approximately 15%.

Requirements

• Bachelor’s degree in an associated functional discipline.
• At least 12 years of experience in clinical research, operations, or a related area.
• At least 5 years of experience in GCP auditing.
• Strong knowledge of multiple therapeutic areas, such as neuroscience and oncology, and 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.
• Demonstrated ability to influence and collaborate effectively with senior stakeholders while maintaining Quality’s independence and authority in challenging, high-pressure situations.
• Technical and administrative capabilities to independently conduct routine, complex, and for-cause audits.
• Knowledge of data integrity controls and systems quality for the clinical area.
• Strong analytical and report-writing skills.
• Ability to travel approximately 15%.

Nice To Haves

• Advanced degree.
• Prior experience in site monitoring and study management.
• Knowledge of GxP systems, including computer system validation and associated regulations.

Responsibilities

• 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 to reskill and upskill the workforce and adapt it to evolving technologies.
• Design, deliver, and execute the North America CQA strategy, including audit and inspection management and oversight of the Quality management system.
• Provide GCP oversight and assure compliance of projects, products, and programs with company procedures, policies, and applicable regulations and guidelines.

Benefits

• Eligible to participate in the Eisai Inc. Annual Incentive Plan and Eisai Inc. Long Term Incentive Plan.
• Eligible to participate in company employee benefit programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Director