Quality Assurance Manager & Supply Chain

Mission: This combined role requires a strategic thinker with strong analytical, communication, and leadership skills, as well as a deep understanding of both supply chain dynamics and quality assurance principles.
QAM & SC oversees product quality with the strategic and operational management of the supply chain. Ensure goods meet regulatory and safety standards while optimizing procurement, inventory, and distribution to prevent supply chain disruptions and maximize end-to-end delivery efficiency.
QAM is responsible for maintaining and improving the Quality Management System (QMS), ensures all commercialized products are following GSP, balancing regulatory compliance with operational efficiency to ensure product safety, identity, strength and quality.
Particularly, QAM oversees the quality aspects of products produced by external contract manufacturing organizations (CMO), ensure that third-party manufacturer adhere to strict GMP and company quality standards, ensuring all manufacturing, packaging, testing, batch quality comply with EU-GMP guidelines, regulatory filings, and Quality Technical Agreement.
Quality Assurance Management
• QMS: implement, manage and improve quality control measures, standards, and systems to ensure products meet defined quality specifications and customer expectations. This includes developing the quality management approach and ensuring alignment with organizational & regulatory standards.
• Documentation Control: review and approve batch records, edit SOPs, validation protocols, and reports to ensure data integrity.
• CMO Quality Oversight: actively monitor the quality performance of Toll manufacturer through periodic visits, site monitoring, and review of production data.
• Technology Transfer & Validation: oversee tech transfer activities and review process validation batches, including stability data, to ensure consistency.
• Quality Agreement Management: draft, negotiate, implement and maintain Quality and Technical Agreements, ensure clear definition of responsibilities between the company and the toll manufacturer.
• Batch Record Review & Release: review and approve batch manufacturing records (BMRs), analytical data, and in-process checks to ensure compliance before authorizing final product release. Provide final authorization for the release of finished products to the market.
• Deviation & CAPA Management: investigate market/customer complaints and significant quality events, leading root cause analysis (RCA), lead investigations into deviations, non-conformances, implement Corrective and Preventive Actions (CAPA), ensure effective closure.
• Audit, Inspection Readiness & Compliance: lead internal, external audits; supplier qualifications, and host regulatory inspections. Conduct on-site audits and compliance visits to ensure adherence to GMP, SOPs, and regulatory requirements. Process Improvement: Analysing performance data, and developing improvement plans to ensure processes consistently meet compliance and regulatory requirements. This involves identifying errors, inspecting procedures, and ensuring corrective actions are implemented.
• Change Control & Documentation: manage the impact assessment and approval of changes in materials, equipment, or processes. Review and approve changes (change control) related to raw materials, equipment, or manufacturing processes at the toll site.
• Training & Leadership: Manage the QA team, providing mentorship, training, and setting quality objectives for the organization.
• Key Performance Indicators (KPIs): Monitor, analyse, and report quality trends and metrics to senior management.
Supply Chain
• Production Planning and Coordination: Aligning supply chain capabilities with production schedules and demand forecasts to ensure smooth material flow and timely manufacturing.
• Logistics and Distribution: Overseeing the transportation, warehousing, and distribution of goods to ensure efficient and cost-effective delivery to customers or other manufacturers. This involves optimizing transportation routes and managing third-party logistics providers.
• Inventory Management: Maintaining optimal inventory levels for raw materials, work-in-progress, and finished goods to balance service requirements with working capital constraints, while avoiding stockouts. Ensure accurate inventory control and resolving discrepancies related to purchase orders or inbound shipment irregularities.
• Data Analysis and Strategy: Analysing supply chain data to identify areas for improvement, creating strategies to increase efficiency and speed, and developing policies to optimize the entire supply chain.
• Audit and Risk Management: Conduct internal, external audits; identify and mitigate risks within the supply chain and quality processes, such as disruptions, delays, and quality issues, and developing contingency plans.
Combined Responsibilities:
• End-to-End Oversight: Managing the entire product lifecycle from sourcing to delivery with a keen eye on both efficiency and quality.
• Cross-Functional Collaboration: Working closely with other departments such as R&D, operations, finance, and sales to ensure seamless integration of supply chain and quality functions.
• Performance Monitoring and Reporting: Establish performance metrics for supply chain and quality, monitor key indicators, and prepare reports for senior management.
• Team Leadership and Training: Leading and mentoring teams involved in supply chain and quality assurance, ensuring they adhere to safety guidelines and quality standards.
• Problem-Solving: Utilizing analytical and problem-solving skills to address issues that arise in both supply chain operations and quality control.