Head of Quality Control
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Lonza is establishing a strategic biomanufacturing base in China using GE Healthcare Solutions. With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market. You will be be joining Cell Culture Development team within Clinical Development in Lonza Guangzhou, China. You will be responsible for the following groups within the department: Raw Material, Analytical, Biochemistry, Microbiology, Environmental Monitoring, Assay validation/transfer, laboratory information and sample logistics.
- Member of the Site Leadership Team
- Responsible for the development and implementation of a Quality Control strategy to meet business goals.
- Responsible to ensure the Quality Control operations comply with current Good Manufacturing Practices and safety regulations.
- Responsible to ensure Quality Control participation in the multidisciplinary customer teams (Information Processing Technique) and the global Quality Control work teams.
- To evaluate and prioritize Quality Control projects in the medium and long term, ensuring that the human, technical and financial resources are focused on the achievement of strategic objectives.
- To lead the development and implementation of improvement systems in the area in line with the Operational Excellence strategy.
- Plan resources for Quality Control to support projects and testing in alignment with production activities.
- To lead the method transfer activities for customer projects in Quality Control.
- To lead from a Quality Control standpoint audits/inspections by customers and/or regulatory agencies.
- To ensure the development and coaching of Quality Control staff in order to improve their performance, abilities and competences.
- Drive the timely release of test results and approval of certificate of Analysis to support batch release.
- Ensure collaboration between Quality Control and all other functions.
- Any other duties as assigned by your Supervisor/ Manager
- Solid current Good Manufacturing Practices Environment In related Quality Control/Quality Assurance Field
- Rich experience in team management
- Technical experience in Mammalian Cell Culture Manufacturing Environment Is preferred (Manufacturing, Laboratory or Engineering)
- Experience Participating in Domestic and International Regulatory Inspections is required.
- Experience working in a Contract Manufacturing Facility and having ability to understand the requirements and expectation of clients in a customer service/satisfaction based organization
- Experience in Corporate Quality System initiatives (Six Sigma, Lean, Total Quality Management, etc.) a plus
- Skillful knowledge of Microsoft Windows and Microsoft Office (Excel, Word, Project, PowerPoint etc)
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.