QA Manager Compliance Fill & Finish 80-100% (m/f/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 investments of the company in Stein (Switzerland) Quality SGIE (Strategic Growth Investments & Engineering) is looking for an experienced Quality Assurance Manager (f/m/d) responsible for the Commissioning & Qualification (C&Q) compliance of an aseptic fill-finish drug product manufacturing facility CAPEX project.
Responsible for the quality oversight and regulatory aspects of the assigned CAPEX project
Ensuring C&Q compliance of GMP systems related to the aseptic fill-finish facility (equipment/utilities/facilities) during the project management lifecycle from design engineering through to the initial C&Q and handover phases
Reviewing and approving C&Q documents of GMP systems as well as related changes and deviations
Supporting audits and regulatory inspections (Swissmedic, FDA, etc.)
Providing leadership and guidance to project team members on C&Q strategy and issues
Ensuring that decisions are fully supported by global and local Quality, as well as Regulatory
Escalating issues in an open and timely manner and take leadership for their resolution
Academical degree (minimum Bachelor) in Engineering, Life Sciences or related field, or equivalent work experience
Significant experience in the GMP regulated pharmaceutical industry, preferably in a role within a Quality Unit
Experience in a QA role for the C&Q of GMP systems related to aseptic fill-finish processes and facility (filling equipment, lyophilization, clean utilities, and clean room facilities)
Fluent 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.