Michael G. Email & Phone Number

Israel

As head of Manufacturing I’m responsible for overseeing all aspects of the production of solid oral dosage forms, including tablets granulation, compression, capsulation and coating, ensuring that manufacturing processes meet regulatory, quality, and safety standards. This role involves strategic planning, process optimization, and resource management to maximize production efficiency while maintaining product integrity.Key responsibilities include:Leading the manufacturing team to achieve production targets and optimizing processes to enhance productivity and reduce costs.Ensuring strict adherence to GMP (Good Manufacturing Practices) and other regulatory requirements, coordinating with Quality Assurance to maintain compliance.Driving continuous improvement initiatives across production lines to improve yield, reduce downtime, and enhance quality.Collaborating with R&D, Quality, Engineering and Supply Chain departments to support new product introductions, scale-up, and product launches.Managing budgets, staffing, and training programs, fostering a culture of safety and operational excellence throughout the department.

Kfar Sava, Center District, Israel

As Site PMO I’m responsible for overseeing and managing “site level” projects throughout their life cycle with primary purpose of establish and maintain standardized project management practices, tools, and methodologies across the organization to ensure consistent and effective delivery. Plays an integral role in defining and executing site strategy, aligning project goals with long-term site objectives and growth initiatives. Collaborates closely with leadership to identify key strategic opportunities, ensuring that projects support and enhance the overall site roadmap. Key functions include:Project GovernanceMethodology and StandardsResource ManagementRisk ManagementReporting and MonitoringKnowledge ManagementServes as a strategic partner, helping project managers and teams succeed in delivering projects on time, within budget, and meeting the desired objectives in fields of: Operations Supply chain Customer Service And People - our most valuable resource. Reporting to Site General Manager

Abic Site, Natanya, Israel

Led and supported comprehensive development and enhancement initiatives at Teva Pharmaceuticals, overseeing infrastructure, machinery, automation, and production processes. Successfully navigated the design change process, implementing best practices and ensuring seamless execution from requirements development to change order implementation.Defined, implemented, and validated R&D production line processes, conducting meticulous process tests, validations (IQOQPQ), and investigations. Upheld engineering documentation standards in adherence to GMP/GDP, consistently enhancing content accuracy.Ensured compliance with federal and international regulations (ISO13485, 21CFR Parts 210/211/820) in a cGMP production environment. Spearheaded cross-functional teams, collaborating with commercial, quality, operations, and R&D to achieve strategic goals and project milestones in a matrix management structure.Proactively identified business proficiency opportunities, unmet needs, and cost-saving requirements. Managed software monitoring and control systems (LMS) with integrated electronics, enabling comprehensive data collection for parameters like temperature, humidity, pressure, and more in remote research and production systems.Collaborated closely with Quality, EHS, R&D, and Production teams to review and approve operations, maintenance, setup, verification, and validation of equipment, processes, and related documentation.

Israel

Oversaw the transition of Heart Failure Diagnostic and Monitoring devices from Development stages to Mass Production. Led Configuration Management, Cost Reduction, Lean Methodology, Supplier Localization, Process Optimization, and NPI initiatives. Managed a team of engineers directly (Mechanical, Electrical, Configuration, PM) and provided indirect oversight to production technicians through detailed KPIs, plans, and ongoing effectiveness/progress monitoring.Collaborated closely with the Quality team to uphold and enhance the company's operational standards across R&D, development, NPI, and Mass Production phases. Ensured compliance with CFDA, FDA, and ISO13845 regulations throughout all stages of product development.

Guangzhou, Guangdong, China

As the Operations & QA Director, I undertook the ambitious task of planning and establishing a medical manufacturing facility in Guangzhou's Science City, China, from inception. This involved the development and manufacturing of Class II medical products for ECG diagnosis and monitoring, owned by G Medical Innovations Ltd in Israel.Under a challenging 1.5-year timeframe, I successfully guided the facility through an ISO13485 audit by SGS and ensured compliance with FDA QSR. In my role, I assumed responsibility for the entire Quality Management System (QMS) and Operations, encompassing Warehouse Management, Manufacturing, capacity planning, and recruitment.

Israel & China (Shenzhen) Branches

Led the engineering support and development of diverse medical devices (Class II & III) for esteemed clients such as J&J, Medtronic, Unilever, and others. Oversaw the entire product lifecycle, including NPD/NPI, equipment FAT, process and machine validation (IQOQPQ, xFMEA, etc.), and comprehensive Risk management.Took charge of Change Control Management (ECR/ECO/ECN) and spearheaded the development of Jigs & Semi-automation. Managed a team of 15+ engineers directly (Mechanical, Electrical, SW) and played an indirect role in defining KPIs for over 1,000 production operators across more than 20 assembly lines.

Tel Aviv Area, Israel

As PM, R&D Mechanical Design Engineering role in the medical industry I managed projects related to the research and development of medical devices. Responsibilities typically include manage the design of systems & mechanical design aspects (using Solidworks). Coordinating with cross-functional teams, ensuring adherence to regulatory standards, and driving innovation in product development. This role was often required a combination of project management skills, mechanical engineering expertise, and a deep understanding of the medical device industry's regulatory landscape.

Ramat Hovav, Hadarom (South) District, Israel

Mechanical Engineer with a focus on maintenance in a pharmaceutical company. The primary role involves ensuring the reliability and optimal performance of mechanical systems and equipment crucial for pharmaceutical production. Responsibilities include developing and executing preventive maintenance schedules, troubleshooting and resolving mechanical issues, and ensuring compliance with regulatory standards such as GMP. Proficiency in utilizing tools for condition monitoring & predictive maintenance

Bachelor Of Science (Bs), Mechanical Engineering

Master Of Business Administration - Mba, With Dean’S Honor

Master'S Degree, Systems Engineering

Lean Six Sigma Black Belt Certification