QA Manager

vor 16 Stunden

Stein, Schweiz Lonza Vollzeit

Switzerland, SteinToday, 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 leader responsible for the GMP compliance of a fill-finish drug product manufacturing project as Project Quality Lead (f/m/d).

Key responsibilities:

- Responsibility for the quality oversight and regulatory aspects of the assigned CAPEX projects
- Ensuring CQV compliance of GMP systems (equipment/utilities/facilities) during the project management lifecycle from design engineering through to the initial CQV and handover phases, with regulatory requirements, industry and company standards
- Reviewing and approving CQV 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 CQV strategy and issues
- Ensuring that decisions are fully supported by global and local Quality and Regulatory
- Escalating issues in an open and timely manner and take leadership for their resolution

Key requirements:

- Bachelor or Master's degree in Engineering, Biotechnology, Pharmacy, or another discipline in natural sciences
- Several years of experience working in the GMP-regulated pharmaceutical industry
- Experience in the following fields is necessary: engineering, manufacturing, quality assurance
- Significant experience in a QA role for the qualification and validation of GMP systems related to aseptic filling equipment, 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.

**Reference: R47371**:

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