Mamdouh Mahmoud

• Managing the Quality Assurance, Quality Control, Validation, and Compliance Departments, while also supporting overall plant operations in the role of Assistant Plant Manager, with the following combined responsibilities:

Key Responsibilities as Quality Manager:

• Host regulatory authorities and corporate inspections within all the company sites and participate in providing responses.
• Contact and respond to all regulatory authorities for any requirements.
• Maintain approvals from all authorities by implementing quality culture awareness to ensure readiness for any external inspection.
• Manage personnel reporting to the quality function to effectively develop, recruit, train, evaluate, motivate, delegate, and monitor their work.
• Manage the implementation of the company's compliance functions and plans.
• Develop, maintain, and update the quality system in accordance with GMP requirements.
• Conduct periodic meetings with quality team members regarding work priorities and departmental updates.
• Direct the Quality Assurance, Quality Control, Validation, and Compliance departments.
• Lead process improvement initiatives and ensure compliance with internal and external regulatory expectations.
• Oversee readiness and audit preparedness for SFDA and other regulatory inspections.

Key Responsibilities as Assistant Plant Manager:

• Participate in developing and implementing business strategies.
• Coordinate with distribution and marketing teams to receive product-specific marketing plans.
• Develop production plans aligned with marketing forecasts to ensure timely fulfillment of market demand.
• Resolve technical and administrative issues that may hinder the execution of production plans.
• Facilitate internal coordination across all manufacturing departments to ensure process harmony.
• Implement timely corrective and preventive actions to avoid any disruption in production.
• Ensure the availability of required resources (manpower, raw materials, equipment readiness) to meet production targets within the agreed timeframes.
• Supervise daily operational execution and escalate potential bottlenecks proactively.
• Support strategic plant-level decision-making by providing operational insights and improvement proposals.
• People Management: handle team affairs (leaves, vacations, performance management, coaching, and training).
• Improve operational efficiency and reduce waste through process standardization.
• Develop and monitor departmental budgets, resource utilization, and key performance indicators (KPIs).
• Key Achievements:
• Led full implementation and GMP certification of Saudi Arabia's first vaccine manufacturing facility.
• Passed SFDA, ISO 9001, 17025, 13485, 45001, and 14001 audits successfully.
• Developed and executed a company-wide compliance function across multiple departments.
• Successfully led the first-in-country vaccine registration process with SFDA.
• Improved production process and increased manufacturing efficiency by 130%.
• Reduced production waste and increased yield from 70% to 95%.
• Cut production operational expenses by over 10% within one year.
• Increased weekly production capacity by 150% with no additional cost.