QA Manager Operation

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.

In this role, you will be a member of a small QA team that will ensure the quality oversight of a new facility and drug product produced therein. You will be involved in transfers of manufacturing processes, review and approve manufacturing SOPs (Standard Operating Procedures) and recipe, release or reject drug substances on behalf of the Responsible Person

Key responsibilities:

  • Be involved in all facility start-up activities as well as process transfers
  • Responsible for defining the bill of material and be involved in all activities required to qualify raw materials
  • Facilitate discussions within internal cross-functional teams such as MSAT (Manufacturing Science & Technology), Manufacturing and Quality Control
  • Review and approve manufacturing recipes
  • Perform batch record reviews in the Manufacturing Execution System
  • Review and approve Discrepancy Records and Change Requests
  • Support the definition of preventive and corrective measures (CAPAs), approve them and track their timely implementation and effectiveness
  • Release Drug Substance batches
  • Review and approve SOPs and project related documents; support and approve quality risk analysis (e.g. FMEA)
  • Write or revise SOPs in your area of expertise
  • Support cGMP training programs to ensure staff is trained
  • Be involved in customer audits as well as in regulatory inspections and support all activities to ensure inspection readiness of the department
  • Actively support the Quality culture as a role model

Key requirements:

  • Bachelor in Biotechnology, Biology, Chemistry or other natural science;
  • Profound working experience in the area of biopharmaceutical manufacturing
  • Knowledge of biotechnological manufacturing processes and filling process as well as in cGMP
  • Good communication skills
  • Strong team orientation
  • Structured, focused and well-organized working attitude, solution-oriented
  • Open-minded for new ideas and suggestions
  • Fluency in English

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: R37714