About this role
Job Purpose & Core Mandate
The Manufacturing Excellence Leader is globally responsible for driving operational efficiency, cost optimization, and business transformation across all Formulation and API manufacturing facilities. This corporate governance role is tasked with tracking daily Overall Equipment Effectiveness (OEE), eliminating material waste, scaling up capacity utilization, and embedding Lean/Six Sigma frameworks while keeping the plant 100% compliant with international GMP expectations.
Detailed Key Result Areas (KRAs) & Responsibilities
1. Process Improvement & Workflow Transformation
• Cycle-Time Compression: Map end-to-end manufacturing workflows to compress cycle times, streamline unit operations, and boost overall plant productivity.
• Online Documentation Efficiency: Optimize manufacturing desk work and online logging systems to ensure frictionless, contemporaneous documentation without slowing down the line.
• Lean / Six Sigma Execution: Institutionalize Continuous Improvement (CI) projects utilizing Lean, Six Sigma, Kaizen, 5S, and Value Stream Mapping (VSM) to eliminate the 8 wastes (Muda).
• Yield & Material Preservation: Actively track batch yields and run localized diagnostic initiatives to eliminate active ingredient losses during chemical synthesis (API) or dosage formulation.
2. Capacity Utilization & Demand Alignment
• OEE Governance: Monitor and analyze daily Overall Equipment Effectiveness (OEE) metrics for all equipment across every Formulation and API plant, building rapid recovery actions for underperforming lines.
• Rated Capacity Matrix: Systematically evaluate the Actual vs. Rated Capacity of production hardware, engineering out bottlenecks to squeeze maximum value out of capital machinery.
• Supply Chain Synchronization: Harmonize production shop floor execution with inventory controls and commercial demand forecasts to maintain a lean pipeline, eliminating both stock-outs and expensive overstocking.
• Cross-Stage Coordination: Act as a central alignment node between Bulk Compounding/Synthesis, Filling/Isolation, and Primary/Secondary Packaging lines.
3. Quality & Compliance Excellence
• cGMP Defensibility: Ensure every operational change, line optimization, and efficiency project maintains absolute compliance with global Good Manufacturing Practices (GMP).
• Audit Preparedness: Directly review internal inspection trends and external FDA audit observations; build long-term, fail-safe procedural correctives to ensure zero repeat citations.
• Proactive Gap Assessment: Run routine systemic health checks to uncover compliance vulnerabilities before regulatory agencies flag them.
• Equipment Calibration & Asset Integrity: Oversee asset life-cycles to ensure validation, predictive maintenance, and calibration programs guarantee peak equipment uptime and precision.
• Quality Guidance Partnership: Act as a strategic advisor to the Quality Assurance (QA) team, helping them construct bulletproof responses and implementation paths for regulatory inspection audit findings.
4. Industrial Engineering & Strategic Manpower Modeling
• Scientific Workforce Planning: Apply advanced Industrial Engineering (IE) techniques to accurately model workforce requirements against seasonal demand spikes and volatile project timelines.
• Machine-to-Man Mapping: Conduct rigorous time-and-motion studies to map headcount precisely to active machinery, optimizing labor allocation while preventing expensive overstaffing or high-risk understaffing.
• Asset Maintenance Control: Optimize structural operations to protect and extend the working lifespan of the company's manufacturing capital and facilities.
• Profitability Vector: Directly impact the plant’s bottom-line profitability by running a leaner, faster manufacturing network capable of shipping customer orders on time.