Document Lifecycle Management

Act as the QA representative and main contact person for external archiving services, ensuring third-party compliance with Lonza standards.

Direct the handling of GMP documentation exceeding defined retention periods, determining if destruction or customer dispatch is required.

Manage the evaluation process for retain samples exceeding retention dates, collaborating with QA Operations and project owners to reach compliant outcomes.

Experience in Quality Assurance or Documentation Management within a highly regulated GxP/GMP environment.

Deep understanding of Data Integrity and archiving regulations (e.g., Annex 11, 21 CFR Part 11).

Strong decision-making skills with the ability to evaluate risks regarding document retention and destruction.

Excellent communication and coordination skills to liaise effectively between QA Operations, document owners, and external partners.

High attention to detail and organizational skills to manage complex documentation lifecycles and retention schedules.

Fluency in English (written and spoken) is required for this site-critical role, German language is a plus.

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.