Director, Clinical Quality Assurance

Eisai•Nutley, NJ

1d•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 and EU requirements, FDA, PMDA, and ICH. The position independently conducts audits and oversees and guides audits of study sites, clinical vendors, clinical documents, and internal processes. It facilitates sponsor health authority inspections of global clinical facilities and study sites, and supports CQA staff development through cross-functional and external partnerships. There is potential for direct people management. The position may be remote, with a remote-work arrangement for candidates near an Eisai location consisting of 2–4 days in the Nutley or Exton office per month and 1–2 audits quarterly. Remote audits are held in Nutley, and CQA staff are expected to be present in Nutley for inspections or critical inspection-management activities. Candidates near Eisai’s NJ/PA location are preferred. Travel is approximately 15%.

Requirements

Bachelor’s degree in an associated functional discipline; an advanced degree is preferred.
Minimum 12 years of experience in clinical research, clinical operations, or a related area.
At least 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.
Strong knowledge of multiple therapeutic areas, such as neuroscience and oncology, and ability to translate protocol objectives into auditable activities.
Ability to influence and collaborate effectively with senior stakeholders while maintaining Quality’s independence and authority in challenging, high-pressure situations.
Technical and administrative capability 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

Prior experience in site monitoring and study management.
Knowledge of GxP systems, including computer system validation and associated regulations.
Advanced degree.
Candidates near Eisai’s NJ/PA location are preferred.

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 as technologies evolve.
Provide potential direct people management.
Provide GCP oversight and assure compliance of projects, products, and programs with company procedures, policies, and applicable regulations and guidelines.