Sawiris Information Systems Validation LLCAn IT Risk, Quality Assurance and Compliance Management leader with 33 years of experience in the life sciences industry, with a focus on leading and enabling end to end quality / compliance processes associated with information technology, research, clinical, pharmaceutical, and manufacturing / laboratory operations. Recognized expert in leading digital transformation for critical quality and compliance processes such as GxP / FDA compliant Computer System Validation frameworks, Software Testing / Release Management programs, Vendor Management services, Technical Writing / Quality / Compliance Management services, and various process optimization programs as well as data integrity and information risk management programs. Demonstrated leadership in managing cross-functional and global teams to drive transformation and achieve business objectives. Mr. Sawiris will also provide support for software vendor audits, mock audits, data integrity assessments, user account access reviews, pre-approval / BIMO / and other FDA / regulatory inspections, computer system validation / software testing / SDLC projects & training, six sigma quality system improvement projects, managing change controls and CAPAs, and program / project management services.High energy, business-oriented leader with in-depth knowledge of numerous business and IT related subject matters. Exceptional organizational, creative, coaching, communication, critical thinking, and problem-solving skills. Extremely analytical, able to determine root causes of complex problems and evaluate situations from strategic and tactical perspectives for effective, rapid resolutions that optimize the business needs. Focused, hardworking, collaborative, and flexible, with an inclusive style that sets the example of personal and team accountability. Mr. Sawiris demonstrates uncompromising ethics and integrity.
Listed skills include Software Development Life Cycle, Cmmi, Itil V3 Foundations Certified, Software Testing Life Cycle, and 24 others.