סקירה כללית
A global pharmaceutical company is seeking a Quality Systems Manager to lead quality systems and compliance activities within a GMP-regulated manufacturing and development environment. This role combines people management, regulatory inspection readiness, and quality systems ownership, with strong interfaces across Quality, Manufacturing, R&D, Supply Chain, and global stakeholders. Key Responsibilities: * Manage and lead the Quality Systems team, including workload management, goal setting, training, and professional development * Lead preparation and support for regulatory authority inspections and customer audits (including FDA), including documentation readiness, participation during audits, and follow-up on commitments and CAPAs * Own annual quality reports, Management Review presentations, quality policies, and risk assessment documentation * Maintain, update, and implement regulatory guidelines, pharmacopoeias, and global SOPs; develop and deliver relevant training * Lead raw material and supplier quality activities, including supplier and material qualification, performance monitoring, supplier audits, quality agreements, and related documentation * Define and maintain document control policies; support electronic document management systems (eDMS) and oversee site archive operations * Support GMP activities in R&D by defining quality involvement and governance for development processes Requirements: Education: * BSc or higher in Biotechnology Engineering, Pharmaceutical Engineering, Biomedical Engineering, Chemistry, Biochemistry, Biotechnology, Life Sciences, or Pharmacy Experience: * At least 5 years of managerial experience * Experience working in the pharmaceutical industry in GMP environments * Strong knowledge of applicable GMP regulations * Hands-on experience participating in regulatory inspections, with emphasis on FDA audits * Experience in supplier quality management and supplier audits * Experience in writing quality policy documents and managing quality documentation systems Skills: * Excellent written and verbal communication skills in English and Hebrew * Strong interpersonal skills and ability to work in a dynamic, cross-functional environment
דרישות המשרה
* Manage and lead the Quality Systems team, including workload management, goal setting, training, and professional development * Lead preparation and support for regulatory authority inspections and customer audits (including FDA), including documentation readiness, participation during audits, and follow-up on commitments and CAPAs * Own annual quality reports, Management Review presentations, q
