MR. MAZEN BOUGHANEM
Global Strategic Compliance Quality Director with over 22 years of diversified Quality experiences in the scope of Technical Ops, Manufacturing, Commercial affiliates and Distribution within the Pharmaceutical and Medical Device industry including over 12 years in Quality leadership position within a multinational business culture.
His experience covers various type of operations, Sterile (liquid, lyophilized), non-sterile (solids, semi-solids and liquids) and Beta lactam/Cephalosporins including deployment of operational excellence utilizing practical knowledge and expertise to integrate lean manufacturing principles (kaizen tools) within a regulated environment delivering tangible results in process optimization, reducing product defect rate and achieving product cost avoidance.
Experience was acquired globally in North America, Middle East, Africa, and China. Mr. Mazen is a collaborative leadership team member and recognized change agent with critical thinking and problem solving as strengths which resulted in leading quality issue mitigation for sustained improvement and deploying the expected Quality culture. He has a track record for effective collaboration with cross-functional teams to attain and sustain robust and fit for purpose compliant operational QMS across different business processes and new acquisitions in accordance to USFDA, Health Canada and GCC regulations yielded outstanding inspection’s outcome.
Further, engaged in projects for new products launch, geo-expansion, technology transfer and Supply Chain projects transition to outsourcing operations in the USA and China effectively. Currently, he am a collaborative member of the global quality leadership team responsible for defining and enhancing the company’s Quality strategy map, strategic projects and monitoring programs.
Driving globally strategic Quality compliance concepts by partnering with cross functional teams to define tactical approaches, guidance and best practices to arm process owner for effective implementation of critical operational and quality processes such as Pharma 4.0, CPV/OPV, GxP data integrity, etc.