[Alexion Japan] Associate Director, Development Quality of Japan
• Provide Quality guidance to Japan Clinical Development teams.
• Drive inspection readiness for PMDA GCP inspections in assigned portfolio to assure successful outcomes during submission-related inspections.
• Support Director of development quality and Identify, evaluate, and drive the remediation of fundamental risks and quality issues within Clinical Development program(s) to drive quality, in collaboration with Clinical Development, in Alexion’s portfolio.
• In alignment with Sr. Director of development operations and director of development quality at APJ, develops a scheme related to proactive and sustainable quality and compliance for programs/portfolio across Japan Research & development Division
• Serve as the quality expert for global/systemic clinical quality issue investigations, which includes:
o In collaboration with operational issue owners lead Quality Event reportability assessments, investigations and Root Cause Analysis
o Reviews and approves Deviations and CAPAs
o As appropriate escalate issues of critical noncompliance and/or lack of urgency in remediation to Quality R&D and appropriate operational Leadership
• Be accountable for leading PMDA inspection readiness for assigned programs/portfolio including but not limited to:
o Provide leadership and guidance to assigned Japan R&D members
o Support follow up and tracking of inspection commitment and effectiveness check for assigned programs/Therapeutic Area
• Serve in an advisory/ consultative role in development of audit strategy for clinical programs, process and vendor audits.
• Actively participate in meetings driving quality performance
• Represent Quality R&D in leading/supporting Diversity, Inclusion & Belonging
• 10 or more years experience in GCP and quality assurance in tactical capacities
• Established expertise and training in GxP systems. Extensive knowledge of global regulations and standards.
• Significant experience with GxP investigations, risk assessments and CAPA management
• Experience participating in regulatory inspections
• ��Functional planning experience and ability to develop functional vision, priorities and tactics
• Experience with multinational products and regulations as well as with mandated risk management plans
• Bachelor’s degree in life science required. Advanced degree strongly preferred.
• Decision Quality
• Being Resilient
• Drives Results
• Proactive Mindset