Daniela Berkowitz Email & Phone Number

Israel

South District, Israel

Managing two production sites with 180 employees, ensuring operational efficiency and products quality Operational Excellence: Led successful reorganizations and new product development initiatives. Compliance Leadership: Managed quality standards and ensured adherence to environmental health and safety regulations. Team Leadership: Developed and mentored team leaders to foster continuous improvement and productivity.

Be’Er Sheva Area, Israel

Led production and packaging for a biopharmaceutical company with two plants and 150 employees. Manufacturing Leadership: Managed the production of drug substances and drug products across two plants. Quality Assurance: Implemented SOPs and led audits to maintain high standards. Project Management: Coordinated operations with departments to streamline production processes.

Beersheba, Southern, Israel

Led a team of engineers responsible for maintenance, validation, and project execution. Engineering Projects: Managed the validation of systems and equipment across multiple sites. Process Improvement: Spearheaded preventive maintenance initiatives to reduce downtime. Team Leadership: Managed four team leaders and ensured alignment with production goals.o Validation - PQ (writing and performance) for systems and equipment o Preventive and Break maintenance including calibration of the technical systemso Engineering projects DQ / IQ / OQ (writing and execution)

2008 – 2012 | Director of Quality Engineering | Kamada Ltd.Led quality engineering efforts, focusing on validation and regulatory compliance. Validation Leadership: Developed the validation master plan and approved key protocols. Regulatory Compliance: Prepared for FDA audits and worked closely with international regulatory bodies. Team Leadership: Managed a team of 10 engineers and collaborated with cross-functional teams.· Responsibility for validation and qualification of systems and equipment, change management and internal audits (Company and service providers)· Active participant in the transferring process of Company technology to a business partner· Review of submissions to health authorities, collaboration with RA and regulatory entities· Preparation for FDA and other foreign health authorities’ audits (e.g. Brazil, Mexico, Israel, European

Bachelor Of Science - Bs, Chemical Engineering

Master Of Business Administration - Mba