Quality Assurance Compliance Manager
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.
For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland we have an exciting opportunity. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and be responsible to provide quality oversight to commercial testing activities by applying for the position as Quality Assurance Compliance Manager
Key responsibilities:
Lead compliance activities at the DPS site Basel
Execute establishment and maintenance of the Quality Management System at DPS Basel
Acts as first contact concerning compliance issues for shared systems (e.g. LSO, Trackwise)
Ensures the proper qualification of staff by supervising adherence to GMP trainings
Support of audits and inspections organized by the Audit and inspection team
Provide input to quality agreements if needed
Key requirements:
Academic degree in Chemistry, Biochemistry, Pharmaceutical Sciences or related field, preferably PhD
Substantial working experience in Quality Assurance in pharmaceutical industries and GMP environment
Good working knowledge in EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems
Sound knowledge in compliance systems for document life cycle management, workflow tools and training management
Excellent communication and decision-making skills
Fluency in written and spoken English, German is 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.