QA Documentation & Reporting Manager IBEX™
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.
We are looking for a QA Documentation & Reporting Manager IBEX™ (m/f/d) to extend our team in Visp The QA Documentation & Reporting Manager IBEX™ (m/f/d) reports to the Quality Systems Team Leader IBEX™ and will also working in close collaboration with Operations functions to ensure adequate readiness, compliance and maintenance of the documentation system within IBEX™.
- Participates in setting IBEX™ Solutions KPIs; collects and evaluates on a regular basis KPI data suitable to assess the effectiveness of the Quality Systems
- Writes and revises SOPs in his/her area of expertise
- Works in close collaboration with Operations to guarantee a proper development and readiness of the Documentation implementation within IBEX™ Solutions; collects and evaluate data from different stakeholders (e.g. Operations) to be reported as part of the QMS processes (e.g. Track & Trend, Quality Council)
- Ensures that the impact of new or revised global guidance documents on the local quality system is assessed and that appropriate measures are defined and implemented where necessary
- Acts as Subject Matter Expert for Documentation/GMP compliance issues at the site
- Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
- Bachelor, Master degree or PhD in Biology, Chemistry, Biotechnology, Life Science or related field.
- At least 4-5 years of experience in the GMP regulated pharmaceutical / API industry in a similar role with a strong background in cGMP regulations
- Experienced in the interaction with health authorities (e.g. Swissmedic, FDA etc.)
- Ability to oversee project execution to identify non-compliance from quality standards
- Solution-oriented and strongly team-minded; structured, smart thinking and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
- Languages: German and 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.