Global Site Head

Job description:

• Responsible for leading and managing biologics manufacturing site to ensure alignment with company goals quality standards and regulatory compliance (FDA EMA NMPA ICH etc.)
• Develop and implement manufacturing strategies to improve efficiency yield scalability and cost-effectiveness across all facilities.
• Oversee technology transfer and scale-up activities from development to commercial manufacturing
• Ensure adherence to cGMP standards and promote a culture of quality and continuous improvement.
• Manage and mentor site leadership teams fostering talent development and succession planning
• Collaborate with R&D Quality Supply Chain and Regulatory Affairs to ensure seamless operations and successful product launches.
• Drive capacity planning and resource allocation to meet customer demand and strategic business objectives.
• Lead risk management initiatives addressing manufacturing challenges including troubleshooting CAPA and investigations
• Manage capital projects related to manufacturing expansion process improvement and new technology implementation
• Establish key performance indicators (KPIs) and regularly report on manufacturing performance to senior leadership
• Serve as a senior representative in customer engagements and audits demonstrating operational excellence and transparency

Qualification requirement:

• Possess a college degree in pharmaceutical or relevant specialties or with an intermediate professional technique certificate or a pharmacists license with at least three years of practical experience in pharmaceutical production and quality management among which at least one year in production management familiar with laws and regulations related to production management.
• Working experience in R&D and GMP activity for global pharmaceutical company
• Full understanding of cGMP and high skill of operation and management