【The Opportunity】
Position Summary
The Associate Director, GxP Quality Assurance plays a critical leadership role in supporting the establishment and maturation of the Japan Quality Assurance organization.
Partnering closely with the Head of Quality Assurance, this position leads the implementation and execution of Quality Systems, Quality Governance processes, and GxP Quality Assurance programs required to support a growing Japan Marketing Authorization Holder (MAH) organization. The role provides strategic and operational quality leadership across product launch activities, commercial operations, contractor oversight, quality event management, quality risk management and regulatory inspection readiness.
As the Deputy of Quality Assurance Manager (QAM), the Associate Director plays a key role in supporting decision-making for quality-related matters and provides independent quality oversight to ensure product quality, patient safety, supply continuity, and compliance with applicable regulatory requirements throughout the product lifecycle.
Key Responsibilities
Quality System Development and Quality Governance
•Establish and maintain the Quality Management System for the Japan MAH organization.
•Lead Quality Governance activities and provide strategic direction for Quality Systems and Quality Compliance programs.
•Serve as the Deputy of QAM and maintain appropriate backup and support mechanisms for critical QA responsibilities.
•Drive continuous improvement of quality processes, procedures and compliance programs.
Product Launch Readiness
•Lead Quality Assurance activities supporting product launch and commercialization in Japan.
•Ensure effective implementation and integration of Japan-specific regulatory requirements into the Global Quality System throughout the product lifecycle.
External Partner Management
•Conduct quality audits of external partners.
•Establish, negotiate and manage Quality Technical Agreements (QTAs) with Contract Manufacturing Organizations (CMOs), logistics providers, warehouses, call centers and other GxP service providers.
• Provide Quality oversight of outsourced activities and monitor compliance with applicable regulatory and
company requirements.
Market Release and Product Quality Oversight
• Ovesee CMO activities and Review and/or approve records supporting product release activities.
• Perform final quality review of significant quality events and provide independent quality assessments to
support product disposition and release decisions.
Quality Event Management
• Provide Quality oversight for Deviations, Change Controls, CAPAs, Product Quality Complaints, Quality
Information and other quality events.
• Review quality risk assessments, investigation outcomes and proposed corrective actions.
• Conduct quality reviews to support final quality decisions on significant quality issues.
• Ensure appropriate cross-functional collaboration and escalation when required.
Quality Metrics and Management Review
• Review quality trend analyses, Annual Product Reviews (APRs) and Management Review outputs.
• Lead escalation of significant quality risks that may impact product quality, patient safety, regulatory
compliance, or supply continuity.
• Monitor Quality System effectiveness through established quality metrics and performance indicators.
Regulatory Inspection Management
• Coordinate inspection readiness activities across Quality Assurance and other business functions.
• Lead inspection preparation, inspection strategy development and inspection management activities.
• Serve as a key Quality representative during regulatory inspections and audits.