Quality Control Manager, Drug Product

China, Guangzhou

Today, Lonza is a global leader in life sciences operating across three continents. 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.

As QC Manager, you will be responsible to supervise the buildup and lead the DPS QC organization, infrastructure and services for biologics, small molecule and peptide parenteral products for clinical and commercial products.

Key responsibilities:

  • Supervise the buildup and lead the DPS QC organization, infrastructure and services for biologics, small molecule and peptide parenteral products for clinical and commercial products.
  • Ensure delivery of DPS QC services and advice
  • Supervise/ensure installation and qualification of all instruments for DP QC in close alignment with current best practices and regulations.
  • Supervise the department and establishment of QC testing procedures and technologies to support DP services and production
  • Lead and manage a group of staff including lab scientists and analysts. Ensure effective use of resources (time, personnel, equipment, material, rooms), maintenance of equipment, order and safety and health protection.
  • Ensure planning and executing of the assigned organization's growth and development.
  • Perform other duties as assigned

Key requirements:

  • Solid current Good Manufacturing Practices Environment in related Quality Control/Quality Assurance Field
  • Rich experience in team management
  • Technical experience in Quality control management serving biologics, small molecule and peptide parenteral products for clinical and commercial products
  • 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)

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

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.

Reference: R37182