Director, Biologics QA
Director of Biologics QA is responsible for building and managing a biologics QA team, establishing and maintaining quality assurance systems, qualifying and auditing third parties/suppliers, ensuring new facilities and production lines in compliance with cGMP regulations, managing deviation reports and CAPAs, and providing quality annual reports.
· Responsible for building and managing a QA team of biologics, including therapeutic monoclonal antibodies, bispecific antibodies, ADC, and fusion proteins.
· Responsible for establishing, maintaining and continuously improving the quality assurance system.
· Responsible for implementing internal quality management system and obtaining various types of GMP certifications.
· Responsible for coordinating quality audits by third-party audit departments and customers.
· Assess and audit material suppliers, establish and maintain a list of qualified suppliers.
· Assist in the design and construction of new facility and production lines, ensure that all facilities and equipment comply with GMP regulations.
· Organize and coordinate validations and verifications.
· Establish management system for quality control and ensure preparation of quality management system documents.
· Responsible for organizing quality-related training.
· Responsible for deviation investigations and CAPA assessments.
· Assist in investigating and handling quality complaints.
· Responsible for product quality review analysis and providing annual quality review analysis report.
· Bachelor’s degree (master or higher preferred) in pharmacy, bioengineering, pharmaceutical engineering, biochemistry or related fields.
· Ability to communicate in English and Mandarin.
· A minimum of 5 years of experience in quality management of biopharmaceutical products.
· Experience in facility construction, production site verification, and GMP certification (US or EU certification).
· Experience in organizing a team to build a quality management or quality assurance system.
· Experience in Quality Management in Europe and the United States is preferred.
· Familiar with drug regulatory policies and GMP regulations.