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Khaled Hossam

@khaledhossam

Message

I build GMP-compliant quality systems and QC laboratories for pharmaceutical manufacturing operations.

Rwanda

Message

What I'm looking for

I’m open to relocating with support to issue a work permit, including where relocation packages are not available.

At BioNTech Rwanda, I support quality operations and quality-system establishment for a greenfield pharmaceutical manufacturing project spanning drug substance, bulk drug product, and fill & finish operations.

I’ve established QC laboratories from scratch, implemented Veeva eQMS and LIMS platforms, led equipment qualification and method validation, and delivered approximately USD 200K in equipment-sourcing savings while maintaining compliance.

Across more than 14 years with BioNTech and Sanofi, I’ve led GMP quality operations, deviation, CAPA and change-control processes, SAP implementations, inspection readiness, and continuous-improvement initiatives that generated EUR 43K in savings.

Experience

Work history, roles, and key accomplishments

Current

Quality Director

Current

BioNTech Rwanda

Aug 2023 - Present (3 years 1 month)

Supporting quality operations and quality systems establishment for BioNTech's greenfield pharmaceutical manufacturing project in Rwanda, covering Drug Substance, bulk Drug Product, and Fill & Finish operations. Directed establishment of QC laboratories, oversaw implementation of digital quality systems, and led QC staffing and capability-building initiatives.

Quality Management Systems GMP Compliance Deviation Management CAPA Change Control Quality Risk Management laboratory operations Veeva LIMS Equipment Qualification method validation Team Leadership Cost Optimization

Quality Control Section Head

Sanofi Egypt

Nov 2016 - Aug 2023 (6 years 9 months)

Managed QC operations within a multinational GMP-regulated pharmaceutical manufacturing environment, ensuring compliance, operational efficiency, and quality oversight for routine and stability testing activities. Oversaw deviation investigations, OOS/OOT processes, CAPA implementation, and change control activities.

Quality Control GMP GLP Deviation Management OOS OOT CAPA Change Control SOP Development Training Lean Continuous Improvement Budget Management SAP Empower 3 Caducee

Senior Quality Control Analyst

Sanofi Egypt

Mar 2015 - Nov 2016 (1 year 8 months)

Supervised analytical activities for routine and stability testing within GMP-regulated laboratories. Supported investigation and resolution of OOS/OOT results and laboratory deviations.

Analytical Testing Stability Testing GMP OOS OOT Deviation Management SOP Development Training Continuous Improvement

Quality Control Analyst

Sanofi Egypt

Jul 2011 - Mar 2015 (3 years 8 months)

Handled HPLC, Gas Chromatography, UV Spectrophotometer, IR-Spectrophotometer and TOC. Responsible for routine and stability analysis, managing chromatographic columns system, and water analysis of factory stations.

HPLC Gas Chromatography UV Spectrophotometer IR Spectrophotometer TOC OOS OOT SOP Development Process Validation raw material analysis Chromatography Water analysis

Demonstrator

Sinai University

Sep 2009 - Jul 2011 (1 year 10 months)

Prepared and taught laboratory sessions for pharmaceutical chemistry, organic chemistry, and analytical chemistry. Served as a Quality Assurance unit member.

Teaching Medicinal Chemistry Organic Chemistry Analytical Chemistry Quality Assurance