Risk & Data Integrity Specialist

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 Risk and Data Integrity Specialist is involved in supporting Lonza’s core risk and data integrity processes. In this role, you build and continuously improve data-driven risk and maturity matrices in close collaboration with the Lonza network, which meets the business needs and aligns with regulatory requirements and industry best practices. You are a member of the Global QMS/Performance team.

Key responsibilities:

• Responsible for the data acquisition and data management for the global risk and data integrity processes, this includes the acquisition of data from eDMS (Documentum and Veeva), eQMS (Trackwise and Veeva), and Cornerstone (training system)
• Utilize skills in Power BI, Excel, Statistica, and Looker to summarize/track and trend meaningful data
• Support the sites and corporate functions in acquiring/summarizing meaningful data in support of global risk/DI processes and procedures
• Monitor data and assist in the development of “leading/predictive” metrics that enable sites/management to evaluate system health and enable leadership to detect trends and outliers
• Engagement of strong cross-functional relationships to drive global standardization
• Attendance on data governance boards
• Effectively communicate data-driven decisions to middle and senior management to exact needed changes to quality management processes, identify opportunities to utilize AI to automate and standardize data processes
• Development of effective training packages and deliver training, as requested

Key requirements:

• Bachelor/ Master Degree in Biochemistry, Biology, Chemistry, Pharmacy or equivalent.
• Expert in using Excel, Power BI, Statisitica, Looker, and other applications to summarize data from multiple sources into meaningful and impactful data to enable decision-making.
• 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).
• Excellent knowledge of computer systems with demonstrated skills in the use of information management systems in a GxP environment (eQMS, eDMS, 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.