Senior Quality Assurance Officer - New Product Introduction

Geleen, Netherlands

Today, Lonza is a global leader in life sciences operating across five 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.

As a Senior QA Officer, you play a key role in supporting GMP manufacturing activities and ensuring the highest quality standards across our operations. You will work closely with manufacturing teams and act as a key QA partner on the floor to ensure compliant execution of production activities while supporting innovative therapies such as cell and gene therapies and mRNA-based products. In this role, you will also support the introduction of new client processes into GMP manufacturing, helping ensure quality and compliance from early process implementation through routine production.

• An agile career in a dynamic GMP manufacturing environment.
• The opportunity to work on innovative cell and gene therapy and mRNA projects.
• Close collaboration with manufacturing, QA, QC and cross-functional project teams.
• Opportunities to contribute to process improvements and new client programs.
• Compensation programs that recognize high performance.
• A variety of benefits dependent on role and location.

• Review and approve deviations, CAPAs and change controls within defined timelines.
• Support manufacturing teams as a QA partner to ensure GMP compliance during production activities.
• Review batch documentation and support preparation for Qualified Person batch disposition.
• Participate in investigations, root cause analysis and risk assessments for quality events.
• Review and approve SOPs, protocols, reports and other GMP documentation.
• Support implementation of new manufacturing processes for incoming client programs.
• Contribute to continuous improvement initiatives to strengthen quality systems and operational processes.

• Minimum of 5 years of experience in a GMP-regulated pharmaceutical, biotechnology or similar manufacturing environment.
• Hands-on experience managing quality events such as deviations, CAPAs and change controls.
• Strong understanding of GMP regulations and regulatory expectations (FDA / EMA).
• Experience supporting biologics, cell and gene therapy or mRNA manufacturing environments is a strong advantage.
• Ability to work independently, make sound quality decisions and manage multiple priorities.
• Strong communication skills and the ability to collaborate closely with manufacturing and technical teams.
• Experience with quality systems such as TrackWise, SAP or document management systems is a plus.

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.

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.

Ready to shape the future of life sciences? Apply now.