Senior Quality Assurance Officer - New Product Introduction

Senior Quality Assurance Officer - New Product Introduction

Lonza

Geleen, Netherlands

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.

What you will do

• 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.

What we are looking for

• 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.