Associate Director Quality Assurance DPS Growth Project 80 - 100% (m/f/d)

Switzerland, Stein

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.

Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Associate Director Quality Assurance DPS Growth Project 80 - 100% (m/f/d).

Key Responsibilities:

  • Create and lead overall Quality strategy

  • Partner with Senior Project Directors and Senior Project Leadership Team to ensure alignment of Manufacturing and support functions in executing strategy

  • Act as Lead SME for significant quality / GMP issues

  • Develop, direct and maintain the local Quality System

  • Contribute to the development and maintenance of global quality systems in line with Lonza Corporate requirements & standards as well as current regulatory requirements meeting Swissmedic, US FDA and European requirements

  • Perform independent review and approval of project documents

  • Identify opportunities for optimization of operational procedures in order to improve quality and efficiency within area of responsibility

  • Implement a learning culture and vertical/horizontal knowledge management

  • Take part in investigations, troubleshooting, audits and inspections

Key requirements:

  • Master’s Degree or equivalent experience, Quality Management, Engineering or related science discipline

  • Eligible to work as a Qualified Person/FvP in Switzerland or EU with leadership experience

  • Extensive work experience in a regulated pharmaceutical industry including engineering, manufacturing, quality assurance, quality control, R&D and/or drug regulatory affairs

  • Experience of chemical and biological GMP API manufacturing with demonstrated ability to interpret and implement related quality and regulatory requirements

  • Proven management experience in an EMA / FDA regulated environment

  • Excellent working knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation

  • Experience in large projects and QA aspects of facility design would be of advantage

  • Knowledge of modern CQV approaches to minimize time from construction completion to routine production while maintaining compliance

  • Experience in managing customer audits and inspections such as Swissmedic, USFDA, EMA, MHRA Audits

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: R56423