Associate Director, Quality Assurance – Israel

About the role

BeOne is seeking an experienced Associate Director to lead Quality Assurance for its Israel affiliate. The role ensures full compliance with Israeli Ministry of Health (MOH) regulations and BeOne’s global quality standards, while safeguarding patient safety.

Key responsibilities

• Establish, implement and maintain the local Quality Management System (QMS) in line with MOH, GMP and GDP requirements.
• Perform Qualified Person (QP) duties, including batch certification, product release and disposition decisions.
• Oversee all GxP activities such as importation, storage, distribution and disposal of medicinal products.
• Manage third‑party logistics providers, ensuring qualified agreements, audits and performance monitoring.
• Develop and maintain a comprehensive quality training program for GxP personnel.
• Lead investigations for deviations, CAPAs, change controls, complaints, temperature excursions, recalls and product destruction.
• Prepare for and host MOH inspections and internal audits, ensuring inspection readiness.
• Maintain complete and controlled quality documentation, including SOPs and records.

Required profile

• Fluency in Hebrew and English.
• Proven experience maintaining a QMS within a regulated pharmaceutical environment.
• Hands‑on experience with MOH regulatory requirements and GMP/GDP compliance.
• Demonstrated ability to act as a Qualified Person for product release.
• Experience managing third‑party service providers and quality agreements.

Required skills

• Qualified Person (QP) responsibilities
• GMP compliance
• GDP compliance
• CAPA management
• GxP oversight
• Quality Management System implementation
• Regulatory documentation and audit readiness