Pharmaceutical industry leader and well-respected expert in global manufacturing with extensive experience working for major pharmaceutical companies. Exceptional skill in directing global operations and cross-functional project teams supporting commercial and manufacturing organizations. Significant international expertise in chemical production and project management involving design and construction of 6 overseas chemical plants, and starting-up new processes in 9 international locations. Broad experience in non-sterile Drug Product Manufacturing including sustained release tablets and inhalation products. Extensive knowledge in Regulatory Affairs and Compliance leading to successful foreign PAI/GMP inspections located in emerging markets by US FDA, TGA, MOHW and EMEA. Proven ability in identification of opportunities and problem solving skills utilizing Lean Six Sigma, FMEA, Kepner-tregoe and HAZOP analyses.