Senior Manager QA Strategic Growth CAPEX Project Initiation
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.
In order to support the strategic growth investment of the company in Visp, we are looking for an experienced quality leader responsible for the Quality and Regulatory aspects of our CAPEX projects portfolio.
Act as Quality Assurance representative and decision maker for strategic growth investment projects (CAPEX > 2 mCHF) during the initiation phase (“Ideation”, “Feasibility”, “Concept Design” and “Basic Design”, including the CAR preparation and approval process).
Provide expertise and coaching to the project team for policies, procedures and specifications.
Be a member of the Projects Leadership team until basic design completion and CAR approval.
Review and approve project and compliance documents and records
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
Academic degree (Master or higher) in Pharmaceutical Sciences, Biochemistry, Chemistry or related field
Substantial work experience in Quality Assurance and/or Production, Engineering, Quality Control in pharmaceutical industries and cGMP controlled environment,
Profound knowledge in EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems
Excellent knowledge of computer systems, quality tools such as risk based approaches – FMEA, statistical process control, design of experiments and Six Sigma
Strong collaborative mindset, organizational skills, ability to balance multiple priorities simultaneously, ability to solve problems, understanding details and strategic picture, providing practical solutions.
Strong verbal and written communication skills (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.