Quality Management System Specialist

at  Lonza

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.
The Quality Management System is the global process owner of Lonza’s core Quality processes. In this role, you build and continuously improve efficient and effective global Quality processes in close collaboration with the Lonza network, which meet the business needs and align with regulatory requirements and industry best practices. You are a member of the Global QMS/Performance team.

KEY REQUIREMENTS:

• Bachelor/ Master Degree in Biochemistry, Biology, Chemistry, Pharmacy, or equivalent.
• Proven hands-on experience in the development, implementation, maintenance, and governance of modern corporate Quality Systems and electronic tools in the pharma-biotech industry.
• Broad work experience in QA and in-depth knowledge of Quality Systems across different GxP areas and global health authority regulations (drug substance, drug product, medical device, excipients, nutritional products, including in-depth knowledge of FDA/EU regulations.
• Excellent knowledge of computer systems with demonstrated skills in the use of information management systems in a GxP environment (eQMS (Trackwise/Veeva), eDMS (Documentum/Veeva), training (Cornerstone), etc.).
• Operations or laboratory experience in chemical and biological GMP manufacturing (drug substance, drug product etc) is a plus.
• Excellent English skills, both written and spoken; knowledge of additional languages 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

• Responsible for the life cycle management of the owned global GxP Quality processes as well as building and leading a global network of subject matter experts to promote best practice sharing and continuous improvement.
• Drive continuous improvement of core Quality processes (e.g change control, deviation, CAPA, etc) at a global level in combination with improvements for the respective corporate electronic system.
• Process owner of the Trackwise system, including assuring access management concepts, maintenance of the validated state, and chairing the Tracksie change review board.
• Development of effective training packages and deliver training required for the global implementation of those processes.
• Support the sites in the implementation and standardization of the global Quality processes and procedures.
• Support regulatory inspections and customer audits for the owned global Quality processes.
• Engagement of strong cross-functional relationships to drive global quality system.
• Requirements, including chairing Community of Practice meetings (Deviation, CAPA, Change Control).