Quality Director

Responsibilities

• Optimize and improve the quality management system (QMS) for commercial production, including the development of relevant systems and processes.
• Lead quality activities across all stages, from raw material intake to product release and shipment, ensuring product safety, efficacy, and quality.
• Ensure all raw materials, packaging, intermediate products, and finished goods undergo necessary testing and comply with registered requirements.
• Drive the application for production licenses and lead the preparation and submission of BLA (Biologics License Applications) for inspections.
• Assist in establishing the Group MAH (Marketing Authorization Holder) quality management and audit systems.
• Guide the development and exchange of quality management talent within the company.
• Oversee key projects at the commercial production site, providing guidance and empowerment at critical milestones.

Requirements

• Bachelor's degree or higher in Bioengineering, Biotechnology, or a related pharmaceutical field.
• 20+ years of experience in pharmaceutical quality management (15+ years if holding a Master's degree or higher).
• Deep familiarity with China and EU pharmaceutical industry regulations and drug registration standards.
• Proven experience leading or participating in domestic registration inspections and GMP compliance inspections.
• Experience with technology transfer projects involving new products or new processes.
• Strong organizational and management skills with the ability to coordinate internal and external stakeholders.
• Fluent English communication skills, both written and spoken.
• Strong professional ethics and a proactive, decisive approach to problem-solving.

About the Company

BioNTech is a leading biotechnology company pioneering novel therapies for patients. We are dedicated to advancing precision medicine through innovative approaches in immunotherapy and vaccine development.