Group Leader Quality Assurance Microbial Manufacturing

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.

The Group Leader Quality Assurance Microbial Manufacturing is responsible for managing a dedicated QA operations team in microbial manufacturing in Visp. Primary responsibility of the individual is to ensure that all applicable regulatory requirements to maintain a cGMP compliant organization are met. As a group leader, the individual is responsible for managing QA personnel, to provide QA support to all stakeholders and to supervise the batch record review and batch disposition team. As Lonza is a contract manufacturer, the Group Leader Quality Assurance will also act as the quality point of contact for our customers and liaise with our customer counterparts. In addition, the group leader is a member of the site QA management team and thus responsible for maintaining and improving the quality system and thereby ensuring the cGMP compliance of the Visp site.

Key responsibilities:

  • Leads and develops the Quality Assurance Microbial Manufacturing group
  • Ensures effective management and continuous improvement
  • Works with other departments to establish and embed a culture of quality and ensures compliance with current GMP regulations
  • Supervises the batch record review and batch disposition process in alignment with the requirements set by the Responsible Person (FvP)
  • Ensures that incidents, nonconformities and deviations are properly investigated and documented
  • Reviews and approves SOPs and other quality-relevant documents to establish cGMP compliant manufacturing
  • Ensures inspection readiness and supports health authorities inspections within the area of responsibility

Key requirements:

  • Master’s degree, preferably Ph.D. - preferred area of study: Microbiology, Biotechnology or Biology
  • Vast experience in the pharmaceutical, biotechnology or related industry with significant exposure to cGMP or closely related environment. Experience in operations is a plus
  • Good knowledge and understanding of all technical aspects of manufacturing plants as well as good understanding of cGMP and cGMP-compliant systems
  • Knowledge of microbiology is advantageous
  • Fluent German and English required
  • Significant experience in personnel management (leadership, priority setting, timely decision making 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: R23038