Elkhayat
VP QA RA
- Role
- Vice President Quality and Regulatory Affairs, Sms Biotech at SMSbiotech
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Elkhayat
20 + years of Biotechnology and Pharmaceuticals experience in cGMP Manufacturing and Quality Operations, and Risk Management. •ASQ Certified Quality Auditor with experience in leading/participating in compliance and regulatory audits. •Seasoned project Manager with hands on experience in developing World Class business processes, organizational change management, as well as Commissioning & Qualification (PMP certification target for May 2017) •Roche Green Belt/Lean Six Sigma certified process leader with a proven track of records in organizational change management and improvements of Quality Chain. •Quality Supply Chain process expert with focused knowledge in supplier/customer business process integration. •Keen ability of using diversity to drive for results while engraining Quality (mitigating risk/increasing compliance). •Genentech Process Improvement Facilitator “PIF” program certified with skills completing capital Quality Operations and continuous improvement initiatives with total cost savings of $6.2 million. •Seasoned change agent with excellent ability of sponsoring innovation, influencing without authority, and championing organizational change. •Expert Kaizen facilitator with proven results in leading diverse teams/workshops, while delivering Continuous Improvements reducing costs and risks of injuries or regulatory compliance. Winner of Roche/Genentech 2009 and 2010 Process Improvement Awards. •Experienced Risk Assessment facilitator, STATURE Owner qualified, and APICS trained professional with excellent ability of managing supply chain risks. •Dedicated work ethics with strong commitment to professional and personal excellence, and strategic objectives.
Experience
Vice President Quality and Regulatory Affairs, Sms Biotech
Jul 2024 — Present · Lake San Marcos, CA, US
Development of GMP Quality Management System.Clinical trials oversite and Inspection readiness Fostering of Quality culture and GMP Development
Education
UC San Diego
Certificate, Drug/Biologics Quality Program Management
2002 — 2004
University of Phoenix
BS Management, Integrated Supply Chain Operations Management
2009 — 2014
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