Director/Senior Manager, Quality Assurance (Taiwan)

Our client in the pharmaceutical industry specialises in Oral Solid Dosage (OSD) production. They are seeking a highly experienced Director/Senior QA Manager to oversee the development and implementation of their product assurance program, complying with regulatory standards including FDA, EMA etc.

Job Responsibilities:

• Develop, implement, and maintain comprehensive quality programs that adheres to company and regulatory standards of pharmaceutical production from in-coming raw materials to out-going finished goods (OSD products) in a CDMO environment.
• Enhance the product assurance program with global best-in-class practices.

• Ensure cGMP compliance and systems and procedures deployed are in compliance with regulatory requirements.
• Drive internal and external audits to ensure compliance with regulations such as US FDA and EMA
• Maintain strict adherence to cGMP regulations.
• Develop the Supplier Quality Program to ensure production of OSD products meet quality standards, and that their capabilities, competence and capacity meet rising production demands.
• Oversee the release of raw materials and finished products, ensuring they meet required quality standards.
• Lead the QA teams to solve quality issues in collaboration with production team.
• Manage the analytical database for cross-departmental usage, ensuring proper evaluation of stability trends and analytical data.
• Monitor and maintain Quality Management System, ensuring data integrity & internal controls are implemented and effectively translated into Quality SOPs in the pharmaceutical manufacturing plant.

Job Requirements:

• A Bachelor of Science / Pharmaceutical Science or an M.S. degree.
• A minimum of 10 years of experience in the pharmaceutical industry, with at least 4 years of relevant experience in leadership.
• Strong QA operations experience in a cGMP environment is essential.
• Proven leadership abilities, including experience in managing teams, conducting performance reviews, and fostering employee development.
• Strong delegation skills and to drive an empowering work culture in the QA team.
• In-depth knowledge of quality management practices, with a focus on driving continuous improvement.
• Excellent problem-solving skills, with the ability to quickly identify issues and develop effective solutions.