Quality Systems Manager I Global Pharmaceutical Company (3672)

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