GMP Audit Manager

Switzerland, Visp

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.

In Visp we are looking for an Audit Manager QA who is responsible for the planning, execution and documentation of all customer audits and for the management of internal audits (self-inspections) and paper inspections by regulatory authorities as well as the complete support of the QA Management within the Lonza QA Group.

Key responsibilities:

  • Preparing the annual internal audit plan in cooperation with the internal auditors
  • Opening the audit records in TrackWise and assigning them to the internal auditors
  • Oversight of auditor training status and execution of internal audits
  • Preparing the annual internal audit report
  • Organizing of preparation meetings and SME training
  • Coordination with SMEs during inspections
  • Coordinating with Regulator Affairs to provide all required documents
  • Answering queries from regulatory authorities with respect to paper inspections

Key requirements:

  • Ph.D. preferred, Master’s degree with experience also acceptable
  • Understanding of the applicable cGMP regulations
  • German and English, both on a high level, written and spoken are mandatory
  • General knowledge of manufacturing processes and analytical methods
  • Auditing experience, auditor certification is an asset
  • Professional appearance and attitude to establish and maintain excellent working relationship with customers, internal stakeholders and cross-functional teams

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: R20763