Haim Nassir Email & Phone Number

Israel

Director of Quality Assurance and Compliance - Dot Compliance | 2023–Present•Managing the Quality and Compliance department, overseeing activities across all stages of the product lifecycle (SDLC, Agile, Jira, Salesforce Platform and Cloud, AWS Cloud and Open AI).•Develop, implement, and maintain quality systems, ensuring adherence to regulatory standards (CSV according to GAMP5, V&V, V-Model). Maintaining Data Privacy and Data Protection processes (PII). •Collaborate with… Show more Director of Quality Assurance and Compliance - Dot Compliance | 2023–Present•Managing the Quality and Compliance department, overseeing activities across all stages of the product lifecycle (SDLC, Agile, Jira, Salesforce Platform and Cloud, AWS Cloud and Open AI).•Develop, implement, and maintain quality systems, ensuring adherence to regulatory standards (CSV according to GAMP5, V&V, V-Model). Maintaining Data Privacy and Data Protection processes (PII). •Collaborate with regulatory bodies, preparing for audits and ensuring continuous compliance (FDA, CE, GDPR, HIPAA).•Manage customer relations on quality issues and oversee subcontractor and procurement controls.•Drive continuous improvement initiatives and efficiency in quality operations (Implementing AI and Automation abilities, (eQMS, ALM, ISMS). Show less

Israel

Global QA and Compliance Manager - IBM | 2015–2023•Oversaw quality assurance and compliance for GxP-regulated infrastructure as PAAS (IaaS, SaaS).•Managed global Life Sciences infrastructure QA and implemented quality processes.•Ensured regulatory compliance for installation and configuration activities.•Developing and managing quality processes for the qualification of Data Centers in the pharmaceutical industry.

Israel

QA IT Manager - Omrix Biotechnology (J&J Company) | 2012–2015• Led quality assurance for IT and QC systems across multiple sites (Labs, IT, and monitoring system).• Managed a team of CSV engineers and testers, overseeing validation and compliance.• Developed quality methodologies aligned with FDA and CE regulations

Bioness Neuromodulation Ltd.

System QA Manager - Bioness Neuromodulation | 2009–2012•Directed quality activities from R&D to production transfer for multidisciplinary medical devices.•Led validation testing, including embedded systems, hardware, and software.•Oversaw testing for RF, wireless, and coexistence systems.•Design and writing of STP, STD and STR documents including the construction of a Traceability Matrix.

Software Validation Engineer - Tescom Global Software Quality Assurance | 2007–2009• Managed validation projects for pharmaceutical clients, overseeing 12 testers.• Prepared regulatory documents and supported FDA and CE compliance activities.• Managing CSV projects.

Quality Assurance Specialist - Teva Pharmaceuticals | 2000–2007• Assisted in managing QA operations, leading a QA team.• Prepared documentation and procedures for FDA inspections.• Expert in quality process policies and procedures.

B.A, Economics And Management

Full High School And Tech, Electrical And Electronic Specialization