Director/Senior Manager, Quality Assurance (Taiwan)

About the role

A client of Citadel Search in the pharmaceutical industry, specialising in Oral Solid Dosage (OSD) production, is looking for a highly experienced Director/Senior QA Manager. The role oversees the development and implementation of the product assurance program, ensuring compliance with regulatory standards such as FDA and EMA.

Key responsibilities

• Develop, implement and maintain quality programs covering raw materials to finished goods in a CDMO environment
• Enhance the product assurance program with global best-in-class practices
• Ensure cGMP compliance and that systems and procedures meet regulatory requirements
• Drive internal and external audits against regulations such as US FDA and EMA
• Develop the supplier quality program so OSD products meet quality standards and suppliers can meet rising production demands
• Oversee the release of raw materials and finished products
• Lead QA teams to resolve quality issues with the production team
• Manage the analytical database, including stability trends and analytical data
• Maintain the Quality Management System, data integrity and internal controls, and translate them into Quality SOPs

Required profile

• Bachelor of Science in Pharmaceutical Science or an M.S. degree
• Minimum 10 years of experience in the pharmaceutical industry, including at least 4 years in leadership
• Strong QA operations experience in a cGMP environment
• Leadership experience: managing teams, performance reviews and employee development
• Strong delegation skills and ability to foster an empowering QA team culture

Required skills

• In-depth knowledge of quality management practices and continuous improvement
• Excellent problem-solving skills