Head QA Qualification / Validation CAPEX Growth Projects (m/f/d)

Switzerland, Stein

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.

In order to support the strategic growth investment of the company in Stein, Switzerland, we are looking for an experienced Head QA Qualification / Validation CAPEX Growth Projects (m/f/d) responsible with his / her team for the Quality and Regulatory aspects of our CAPEX projects portfolio related to drug product manufacturing.

Key responsibilities:

  • Responsible for the Quality aspects related to Lonza’s Strategic Growth Investments in the assigned network from Basic Design to Qualification, Validation and PPQ.

  • Provide with his / her team Quality oversight and ensure approval of equipment/facility qualification and validation documents as well as associated change controls.

  • Ensure that decisions are fully supported by global and local Quality and Regulatory

  • Escalating issues in an open and timely manner and taking leadership for their resolution

Key requirements:

  • Master degree in Biotechnology, Engineering, Pharmacy or other relevant areas

  • Recognized expert in the area of drug product aseptic filling and packaging, cGMP, facility design, Qualification and Validation.

  • Over 10 years’ experience in a regulated pharmaceutical industry including engineering, manufacturing, quality assurance, quality control, R&D and/or drug regulatory affairs

  • Strong leadership skills and ability to communicate internally and externally at higher levels

  • Structured, organized, proactive and collaborative working attitude

  • Strong verbal and written communication skills

  • Fluent in English and German

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: R34158