The Associate Director, GCP Quality Assurance oversees GCP activities at Eisai, our CROs and Investigator Sites, leads GCP audits and inspection readiness. The successful hire will ensure high quality execution of clinical trials from first in human through commercial marketing authorization of clinical trials. This person will manage cross functional relationships with internal and external stakeholders and be the Lead Quality Assurance representative to clinical teams. This is a high visibility position with great impact potential.
• Be the key point of contact from QA to the Therapeutic Area (TA) business group for ongoing quality oversight and foster principles of Quality by design. • As an ad-hoc member of the global clinical teams (Program and Study level), serve as the key Quality consultant and actively participate in risk and issue management. Lead inspection preparedness and continuous improvement to instill a ‘culture of Quality.’ • Develop/author audit plan and QA strategy for the programs and studies in the assigned TA group. • Independently conduct Clinical Investigator Site Audits, GCP Document Audits (Clinical Study Reports and Trial Master Files), internal Process Audits and support Vendor/System audits. • Author and review reports for audits of sites/ vendors/CSRs across the assigned clinical portfolio (TA). • Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to TA teams. • Manage health authority inspection preparation activities and provide leadership and oversight during inspections. • Compile and analyze audit metrics to communicate trends to business group. • Conduct GCP training sessions for business group. • Manage direct reports (if applicable).
• Bachelor’s degree in associated functional discipline required. Advanced degree is preferred. • Preferably 8+ years’ experience in Clinical Research/ Operations/Data Management or related area. Minimum of 3-6 years of Clinical Quality Assurance auditing. • Technical and administrative capabilities to independently carry out routine, complex and for-cause audits. • Experience of inspection management. • Experience with supervising direct reports preferred. • Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials. • Strong analytical skills and report writing skills. • Ability to demonstrate tact as a representative of the CQA Department. • Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently. • Ability to Travel (approximately 20%). • Work location - Eisai's offices at Woodcliff Lake, NJ.