Full Time

Quality Audit Manager

Posted 1 month ago
Application ends: November 6, 2021
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Job Description

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 bio manufacturing 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 responsible for establishing and maintenance a robustness and cGMP compliance Quality Audit Systems. Follow up Global Quality Compliance (GQC) assessments of GZB Quality Management Systems

Key Responsibilities

  • Lead audit team to successfully organize, implement and maintain Internal Audit Program
  • Lead audit team to successfully manage external regulatory inspections, Customers’ Quality Compliance audits
  • Follow up Global Quality Compliance (GQC) assessments of GZB Quality Management Systems
  • Build up a close and good working relationship with regulatory department and customers.
  • Enhance GMP mindset within GZB
  • Follow-up actions on any compliance issues
  • Perform the gap analysis between GZB QMS & regulatory requirements
  • Coordinate between departments for multiple parallel activities;
  • Foresee advanced topics pertaining to cGMP;
  • Any other tasks as and when assigned.

Key Requirements

  • Bachelor or above in Pharmaceutical Sciences /Biotechnology/equivalent major;
  • Substantial experience in Quality, Compliance or equivalent functions.
  • Solid experience in team management.
  • Fluent in English and Mandarin;
  • Good communication skills
  • Ensures delivery excellence for his/her own goals

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: R31432