Global Head (m/f/d) of Data Integrity - Biologics
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.
Ibex® Solutions (www.ibex.lonza.com) is a modular build complex to develop and manufacture biological products. It enables companies to get access to a complete solution, gaining speed and achieving a simplified value chain. The Ibex® Complex is our contribution to the medicine of tomorrow and possibly the next step in your career? Start your career with Lonza today.
Apply as Global Head (m/f/d) of Data Integrity - Biologics
In order to support the amazing growth of the Biologics Division, the Quality organization is looking for a Global Head (m/f/d) of Data Integrity – Biologics. The role will focus on ensuring that sites from the respective division fall under applicable regulatory and corporate requirements, meet the stated standards in place to understand GxP data being captured at site and how to protect it securely as well as ensure data quality and consistency within sites through monitoring. This role is a unique opportunity to lead a truly global cross functional team and to make an impact at all levels of the organization.
Participation in the data integrity notification process and responsible for investigations, root cause analysis and CAPA remediation when problems arise as well as evaluation of sites for compliance with corporate and regulatory standards
Assist site personnel on DI cases and questions to ensure Lonza and regulatory requirements are implemented and participation in Data Governance Meetings
Mitigate the risk of regulatory findings / observations related to data integrity and foster a strong quality culture in the division related to Data Integrity
Escalate potential issues and report findings as well as oversee data integrity remediation to closure as well as actively participate in procedural revisions/clarifications as the division requires
Participation in Divisional Community of Practice Group to share approaches with similar sites with corporate/regulatory requirements
Bachelor or Master Degree in Chemistry, Biotechnology, Life Science or related working experiences
Previous experience in Quality DI and GMP regulated pharmaceutical industry
Strong leadership experience as well as experience in management communication across complex global organisations
Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
English and German good command are required
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.