QA Investigator

To support the growth of our QA organization in Ghent, we are looking for a QA Investigator who combines a strong quality mindset with excellent stakeholder management and decision-making skills. In this role, you provide quality oversight for the manufacturing of our life-changing CAR-T cell therapy and act as a key partner in the management, review, and approval of investigations in a highly regulated GMP environment. 

As a QA Investigator, you play a critical role in ensuring that manufacturing issues are investigated, documented, and resolved in a compliant and timely manner. You act as a trusted quality partner for Operations, MSAT, QA Release, and other cross-functional stakeholders ensuring that quality risks are properly assessed and that appropriate actions are implemented to safeguard product quality;

You are responsible for;   

• Investigation Oversight & Quality Review: You take ownership of non-conformances from initiation to closure. Each investigation is assigned to a QA Investigator who follows that case throughout its entire lifecycle. While our Operations/MSAT/QA Investigations team are responsible for performing the investigation and root cause analyses, you provide quality oversight, review investigation reports, challenge proposed actions where needed and ultimately assess whether the investigation meets quality and compliance standards. You proactively organize alignment meetings with investigation owners, review draft reports, support stakeholders in defining appropriate corrective actions, and ensure investigations progress according to agreed timelines and priorities. 
• Quality Risk Assessment & Decision Making: You assess the potential impact of non-conformances on product quality and patient safety. You carefully evaluate available information and help determine whether material can still be released or whether additional actions are required. 
• Audit Readiness & Quality Presence on Floor: You participate in monthly quality tours across manufacturing, the warehouse, and support areas to assess GMP compliance, document practices, and audit readiness. In addition, you witness various activities from a quality perspective and provide feedback to ensure compliance with procedures and GMP expectations.
• Stakeholder Management & Quality Advocacy: You collaborate with a broad range of stakeholders including Operations, MSAT, QA Release and other cross-functional teams. You are able to clearly explain quality requirements, defend quality decisions, and escalate concerns when necessary. You build strong relationships across all levels of the organization.
• Continuous Improvement & Project Support: You actively contribute to continuous improvement initiatives by reviewing and supporting process iprovement proposals from various departments. You identify recurring trends, process gabs, and opportunities to strengthen our quality systems and investigation processes. 

• A minimum of a bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Bioengineering, or another relevant scientific discipline.  

• A minimum of two years of relevant experience within a pharmaceutical, biotechnology, cell therapy, or other highly regulated GMP environment.  
• Experience in an aseptic manufacturing environment is strongly preferred. 
• Experience in a Quality Assurance or Investigations is strongly preferred.  

• Fluent English (written and spoken) is required. 

• You have a strong quality mindset and are passionate about compliance and patient safety. 
• You have strong communication and stakeholder management skills that can collaborate and influence at all organizational levels. 
• You are confident to assess complex quality risks and are able to make decisions when working with ambiguity in a fast-paced environment.  
• You are able to perform under pressure, managing multiple priorities simultaneously and maintain oversight across numerous ongoing projects.