Quality Assurance Manager CSV (Capital Projects) (f/m/d)
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 Visp, Switzerland, we are looking for an experienced quality leader responsible for the CSV aspects of our CAPEX projects portfolio.
The position is based in Visp Switzerland, the site is easily commutable from the Bernese Oberland (40 minutes by train from Thun). Visp, also known as the sun center of Switzerland, is located in the Swiss Alps close to Zermatt, Saas Fee, Verbier and Cran-Montana – a beautiful area to go skiing in the winter or enjoying great views during hiking and biking tours in the summer.
Owning all quality related responsibilities for the Computerized System Validation (CSV): activities of dedicated new facilities, equipment and utilities related to the GMP manufacturing of biologics & APIs
Representing the quality department in the CAPEX project organization in regards to CSV
Reviewing and releasing CSV documents and SOPs
Being a Subject Matter Expert (SME) and providing guidance and recommendations to internal or external customers
Bachelor or Master Degree in Biotechnology, Chemistry, Life Science or related field
Significant experience in the GMP regulated pharmaceutical industry; preferable in a role within a Quality Unit
Broad knowledge in CSV, Data Integrity and related guidelines (21 CFR Part 11, EU GMP Annex 11, GAMP5 and the underlying principles of each)
Experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
Working knowledge within electronic document management systems
Fluency in English, German would be an advantage
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.