Quality Management Processes & Systems Manager

Today, our company 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. 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 Quality Management Processes & Systems Manager.

Key responsibilities:

• Ensure GxP relevant Corporate QM Systems are in validated state in accordance with established validation framework.

• Act as Quality Partner for Business, System Owner and IT including

• Drive validation activities and support creation of validation deliverables during project

• Cooperate with Business, System Owner and IT, participate in the operational activities.

• Act as validation SME for internal / external audits and regulatory inspections.

• Contribute to validation framework development and ensure alignment with up to date regulatory requirements

• Support development of quality and validation policies, risk-based standards, and procedures in line with internal and external regulations

Key requirements:

• Bachelors or M.Sc. in Information Technology, Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences or related field

• Work experiences in similar positions in pharma industry

• Deep understanding of computerized QM systems, including document, quality and learning management systems design

• cGMP knowledge and experience in applying it for computerized systems with strong GAMP5 knowledge

• Experience in quality oversight of computerized systems in regulated environment

• Work experience with complex system validation documentation creation and maintenance and interest in working with documentation

• Experience in Computerized System GMP Compliance and Data Integrity

• Excellent communication and presentation skills in English – verbal and written, other languages is a benefit

• Strong analytical skills including process and system mapping abilities

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.