Note: The job is a remote job and is open to candidates in USA. Eisai Inc. is hiring a Director, Clinical Quality Assurance to lead 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 oversight and ensures clinical projects, products, and programs comply with company procedures and applicable regulations and guidelines.

Responsibilities

• 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
• 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

Skills

• Bachelor's degree in an associated functional discipline
• Minimum 12 years in clinical research or operations or related area
• Strong knowledge of multiple therapeutic areas, eg. neuroscience and oncology
• 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
• Ability to Travel (approximately 15%)
• Advanced degree
• Prior experience in site monitoring and study management
• Knowledge of GxP systems including computer system validation and associated regulations, recommended

Benefits

• Eligible to participate in Eisai Inc. Annual Incentive Plan.
• Eligible to participate in Eisai Inc. Long Term Incentive Plan.
• Eligible to participate in Company employee benefit programs.
• For candidates near an Eisai location, Remote Work Arrangement consists of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits are held in Nutley.

Company Overview

Company H1B Sponsorship