Mohamed Yagi

About Mohamed Yagi

The only way to do great work is to love what you do” – Steve Jobs I am an accomplished Quality Assurance Professional with solid experience in quality management, process improvement and risk mitigation. Bringing seasoned leadership across multiple areas, I partner with key departments to facilitate actions and maintain compliance with FDA and international Regulatory bodies for change controls, CAPA, deviations, complaints, and internal GxP audit observation follow-up. My responsibilities encompass maintaining and improving existing quality processes to ensure appropriate and compliant clinical and drug manufacturing operations. In my current role as a Senior Quality and Compliance Consultant, I helped orchestrate a 20% growth in revenue from QA Consultancy services and clinical trial audits. Throughout my career, I have consistently established, implemented, and maintained quality standards to drive compliance in clinical, R&D, and pharmaceutical settings. Specialties: Risk Assessment & Mitigation | Quality Assurance | Supplier & Vendor Management | Compliance Investigations & Audits | Standard Operating Procedures | CAPA Implementation | Site Quality Assessments | Client & Stakeholder Communications While I\'m an intense competitor who wants to excel as an individual, I love collaborating with people from diverse backgrounds and providing guidance to less experienced colleagues. I find a lot of meaning in being a strong member of a team.

Experience

1. Senior Auditor

   SGS

   Jan 2024 — Present · US

   Overview: Seasoned Lead Auditor with extensive expertise in managing and leading audits across multiple standards, including ISO 22716, EU GMP, WHO GMP/GDP, 21CFR210/211, ISO 15378, and ISO 9001. Demonstrated ability to lead integrated audits, manage audit teams, and ensure compliance with global and local procedures. Skilled at evaluating audit evidence, operating certification systems, and delivering thorough audit experiences to clients. Proven track record in training and mentoring auditors, participating in witness audits, and maintaining all necessary credentials.Notable Achievements: Leadership in Auditing: Led comprehensive audits across diverse standards, including ISO 22716, EU GMP, WHO GMP/GDP, ISO 15378, ISO 9001, and 210, 211, demonstrating robust leadership and managerial skills. Inspection Readiness Management: Directed inspection readiness activities, including mock inspections and on-site inspection support, showcasing strategic planning and execution. Regulatory Compliance Oversight: Ensured compliance with global and local procedures, effectively collaborating with regulatory agencies as needed. Team Leadership and Mentorship: Successfully led and mentored audit teams, providing in-depth training and support to enhance team performance and development. Certification System Management: Maintained and updated the SGS Certification System in collaboration with Product Managers and Technical Accreditation CBE, ensuring system integrity and effectiveness. Global Project Leadership: Contributed to and directed global project teams, providing strategic direction for global QA initiatives and demonstrating strong project management capabilities Credential and Standards Adherence: Consistently maintained all audit-related credentials and adhered to internal standards, policies, and procedures, ensuring high-quality audit practices.

Education

• National Ribat University

  Doctor of Medicine (M.D.)

  2001 — 2006

• Mercer County Community College

  Certificate in Clinical development and Regulatory Affair

  2017 — 2018