Director, Clinical Quality Assurance
Eisai US
Summary
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).
Job description
Job Profile Summary
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).
Essential Functions
- Independently conduct audits
- Oversee and guide conduct 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
- Provide skill-building interventions for CQA staff through cross-functional/external partnerships to reskill/upskill and adapt the workforce to evolving technologies
- Potential for direct people management
Requirements
- Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research or operations or related area
- Prior experience in site monitoring and study management is preferred
- Strong knowledge of multiple therapeutic areas, eg. neuroscience and oncology, and ability to translate key protocol objectives into auditable activities
- 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 effectively influence and collaborate with senior stakeholders, maintaining Quality's independence and authority in challenging and high-pressure situations
- 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
- Knowledge of GxP systems including computer system validation and associated regulations, recommended
- Ability to Travel (approximately 15%)
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.
Requirements
- Bachelor's degree in an associated functional discipline
- Minimum 12 years in clinical research or operations 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
- Strong knowledge of multiple therapeutic areas (e.g., neuroscience and oncology)
- Ability to translate key protocol objectives into auditable activities
- Demonstrated ability to influence and collaborate with senior stakeholders
- 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
- Ability to travel approximately 15%
Benefits
- Annual Incentive Plan
- Long-Term Incentive Plan
- Employee Benefits
Company overview
Eisai US is the American pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., a global pharmaceutical company founded in 1941. Headquartered in Nutley, New Jersey, Eisai US operates with a passionate commitment to patient care through its human health care (hhc) philosophy, which places patients and their families at the forefront of all business decisions. The company focuses on two primary therapeutic areas: oncology and neurology, with particular emphasis on dementia-related diseases and neurodegenerative disorders. Eisai US maintains a fully integrated pharmaceutical business model with end-to-end capabilities spanning discovery, development, and marketing. The organization operates commercial and clinical development organizations in New Jersey, discovery labs in Massachusetts and Pennsylvania, and global demand chain operations in Maryland and North Carolina. Notable products in its portfolio include Leqembi (lecanemab) for Alzheimer's disease, Lenvima (lenvatinib) for various cancers, and Aricept (donepezil) for Alzheimer's treatment. With approximately 1,001-5,000 employees in the United States, Eisai US represents a significant presence in the American pharmaceutical landscape, dedicated to addressing unmet medical needs through innovative therapies and comprehensive patient support programs.