Site Quality Head

Quality Management System (QMS) : Lead the development, implementation, and continuous improvement of the site's QMS. Ensure that the QMS is aligned with global standards, regulations, and customer expectations. Oversee all quality-related activities, including quality control, quality assurance, validation, and compliance. Regulatory Compliance : Ensure compliance with all applicable regulatory requirements, including FDA, EMA, ISO, and other local and international standards. Prepare for and manage regulatory inspections and audits. Lead the implementation of corrective and preventive actions (CAPAs) resulting from audit findings or quality issues. Product Quality : Monitor the quality of raw materials, in-process goods, and finished products to ensure they meet the required specifications. Investigate and resolve product quality issues and deviations. Implement robust testing, inspection, and review processes to ensure product quality and safety. Leadership & Team Management : Lead, mentor, and develop the site's quality team, ensuring continuous skill development and knowledge transfer. Foster a culture of quality across the site, engaging all employees in quality initiatives. Set performance goals for the quality department and drive improvements based on KPIs. Continuous Improvement & Process Optimization : Implement continuous improvement initiatives, utilizing tools such as Six Sigma, Lean, or other quality management methodologies. Analyze quality metrics, identify trends, and recommend corrective actions to improve processes and reduce deviations. Drive the optimization of quality processes to improve efficiency while maintaining compliance and high-quality standards. Supplier Quality Management : Manage relationships with key suppliers to ensure the quality of supplied materials meets regulatory and company standards. Conduct supplier audits and implement quality agreements to ensure ongoing compliance. Develop and implement supplier performance monitoring systems. Customer Complaint Handling : Lead the investigation and resolution of customer complaints related to product quality. Collaborate with cross-functional teams to root cause and prevent recurrence of complaints. Communicate with customers regarding quality-related issues and corrective actions taken. Training & Development : Oversee training programs for site employees on quality processes, regulatory compliance, and best practices. Ensure all personnel are trained and qualified to perform their jobs in accordance with the site's quality requirements.