Senior Quality Assurance Manager Strategic Projects

Switzerland, Basel

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.

For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland and Stein, Switzerland, we have 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 Senior Quality Assurance Manager Strategic Projects.

Key responsibilities:

  • Act as Quality Assurance representative and decision maker for strategic projects in the environment of aseptic Drug Product manufacturing and Quality Control testing

  • Responsible for safeguarding Quality Assurance interests when introducing new technologies and expanding existing processes to new applications

  • Establish and upgrade Quality Management Systems and ensure proper qualification of staff

  • Review and approve project and compliance documents and records

  • Adhere and comply to international GMP standards and regulatory requirements

  • Ensure appropriate resource planning, time and cost targets within Quality Assurance

  • Develop and adhere to standards for qualification & maintenance (incl. CSV), production processes, cleaning and validation, method validation and testing

  • Guarantee standards for development of material storage/transport and material/personnel flow, qualification of supplier/material, assessments and documentation

  • Supervises and execute GMP compliance activities in case of changes or updates of regulatory requirements, specific customer requests or unforeseen events like

  • Counsel and support all groups in in projects and GMP aspects

Key requirements:

  • Academic degree (Master or higher) in Pharmaceutical Sciences, Biochemistry, Chemistry or related field

  • Substantial work experience in Quality Assurance in pharmaceutical industries and cGMP controlled environment in Production and Quality Control

  • Profound knowledge in EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems

  • Excellent knowledge in development, testing and manufacturing of chemical and biological drug products

  • Excellent communication, project management and decision making skills

  • Proficient in providing solutions for complex challenges

  • Ability to work independently in a team environment

  • Fluency in English and German

  • Experience in aseptic production environment and large molecules preferred

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: R26366