GlaxoSmithKline (1998–2015) – Held senior roles including Head of Quality and Compliance and Head of Technical, driving GMP excellence, process improvement, and operational strategy across manufacturing sites. Over 27 years of expertise in pharmaceutical production systems, new product development, continuous improvement, and validation processes.
Eng. Thilange’s engineering foundation (Chemical & Process Engineering) combined with an MBA in Strategic Management enabled end-to-end leadership in quality systems, regulatory inspections, and cross-functional manufacturing operations.
Trusted advisor for leading organizations: Pfizer-BioNTech (Rwanda), GIZ, COMESA, BioVax, UNFPA, Yash Life Sciences (Zambia), Kingphar Zambia, Pharmanova Zambia, CPT Pharma (SA), BAT, Pwani Oil Products, Piston Medical, World Plastic, Bahati Agro-processors, and Generic Manufacturing. International assignments with GIZ and the EU supporting SADC countries to achieve WHO prequalification.
Lead Consultant for COMESA – Conducted GMP and ISO/IEC 17025 assessments across 21 Member States and developed capacity-building frameworks for national quality control laboratories. Instrumental in harmonizing regulatory standards and lab competence across the region.
Eng. Thilange bridges international requirements with local implementation: design review, VMPs, cleaning validation, continued process verification (CPV). Aligns with WHO TRS, EU GMP, PIC/S, ISO 9001, ICH Q8–Q12, GAMP 5, and ALCOA+ data integrity principles.
Cross-sector experience includes pharmaceuticals, cosmetics, and food, delivering strategic and technical support to achieve compliance and quality excellence.
Registered Professional Engineer (Engineers Board of Kenya) | Corporate Member – Institution of Engineers of Kenya (IEK).
Secretary General – Kenya Institute of Chemical Engineers (KiCHE) | Member – International Society for Pharmaceutical Engineering (ISPE).
Supports certification in FSMS, OHS, EMS, IMS, QMS and related international standards. Expertise spans business process optimization, FDA standards, ISO 9001/17025, and validation lifecycle management.
Previously served as a Director at the Energy and Petroleum Regulatory Authority (EPHRA) contributing to strategic governance and regulatory oversight.
✔ Production systems · Manufacturing operations · NPD · Continuous improvement · Validation