Quality Management System & Compliance 

• Develop, implement and continuously improve the Quality Management System (QMS). 

• Ensure compliance with GMP, applicable ISO standards, customer requirements and relevant regulatory requirements. 

• Maintain quality policies, SOPs, specifications, standards and quality documentation. 

• Lead internal, external, customer and regulatory audits and ensure timely closure of findings. 

Quality Assurance & CAPA 

• Drive process compliance and quality assurance across all manufacturing operations. 

• Manage deviations, non-conformances, CAPA, change controls and root-cause investigations. 

• Ensure preventive and corrective actions are practical, timely and effective. 

• Promote Right First Time manufacturing, quality-by-design and disciplined process control. 

Quality Control, Laboratory & Product Release 

• Oversee testing, inspection and release of raw materials, packaging materials, work-in-progress and finished goods. 

• Ensure laboratory equipment is appropriately calibrated, validated and maintained. 

• Review and approve test results, Certificates of Analysis, release documentation and product disposition decisions. 

• Ensure effective hold, quarantine, rejection and release controls are maintained throughout manufacturing and warehouse processes. 

• Ensure traceability of materials and products throughout the manufacturing lifecycle. 

Product Quality, Yield & Waste Management 

• Monitor quality performance, process capability and product conformity and drive corrective actions where standards are not met. 

• Lead initiatives to improve production yield and reduce waste, scrap, rework and product losses. 

• Define acceptable process-loss and waste-tolerance thresholds with Operations and monitor compliance. 

• Track Cost of Poor Quality (COPQ) and implement improvement actions that support operational efficiency and profitability. 

Customer & Supplier Quality Management 

• Investigate customer complaints, determine root causes and implement sustainable corrective actions. 

• Monitor quality-related customer satisfaction trends and recommend preventive actions. 

• Partner with Procurement and Supply Chain to improve supplier quality and ensure only compliant materials enter production. 

• Conduct supplier quality assessments and track supplier corrective actions to closure. 

Governance, Reporting & Quality Leadership 

• Lead daily quality reviews and quality escalation discussions and participate in weekly operational and monthly S&OP reviews. 

• Develop quality dashboards, scorecards and management reports and present quality insights and recommendations. 

• Lead, coach and develop the quality team and ensure required competency and training compliance. 

• Build a quality-focused culture across the plant and champion continuous improvement and operational excellence.