Do you have a strong quality mindset and a passion for investigating deviations and driving continuous improvement? As we continue to expand our operations in Ghent, we are looking for a QC Investigation Specialist;

What can you expect?

As a QC Investigation Specialist, you are responsible for managing QC-related deviations and executing qualitative investigations in close collaboration with cross-functional stakeholders. You play a key role in ensuring thorough root cause analysis and defining corrective and preventive actions to reduce future non-conformances. You are responsible for;  

QC Investigations & Deviation Management 

• Reviewing and completing QC non-conformance/deviation investigations in time. 
• Performing root cause analyses using appropriate investigation tools and methodologies. 
• Interviewing cross-functional stakeholders and providing quality input to complete investigation reports. 
• Acting with a high sense of urgency in response to departmental and cross-functional requests. 

Documentation & Technical Writing  

• Documenting QC non-conformance/deviation investigations with detail and clear technical writing jargon.  
• Performing all tasks in compliance with GMP requirements, quality systems, and safety policies. 
• Supporting inspection readiness and interacting confidently with auditors and inspectors. 

Problem Solving & Continuous Improvement 

• Proactively collaborating with internal stakeholders to define, implement and ensure timely completion of effective CAPA’s. 
• Monitoring and reporting metrics related to investigations and CAPA performance. 
• Providing recommendations for process improvements by working cross-functionally. 

Who are we looking for? 

Education

• You obtained a Bachelor's degree or equivalent relevant experience. 

Experience  

• You have hands-on experience in a GMP environment, preferably in quality control. 

 Languages  

• You are fluent in English and/or Dutch. 

 Strengths

• You have strong communication skills that foster collaboration. 
• You have a solution-oriented mindset prioritizing quality and compliance. 
• You are able to act quick and feel a strong sense of urgency.
• You are able to stay calm and motivated under tight deadlines. 
• You are curious and dive deep to find out the root cause of a problem and can think out-of-box when defining improvements and solutions. 
• You have strong documentation skills. 

What do we offer you?

• A meaningful job with an excellent work-life balance, in a 40-hour work week working from Monday until Friday. 
• A supportive and innovative work environment. We value and encourage learning and personal development.  
• The opportunity to work with people from all over the world. 
• A contract of indefinite duration and an attractive salary package complemented by many fringe benefits, such as additional statutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, an end-of-year and performance bonus. 
• Many fun and informal events. 

About Legend Biotech

Legend Biotech is a global biotechnology company dedicated to developing, manufacturing, and commercializing innovative and life-saving cell therapies for the treatment of chronic and life-threatening diseases, such as cancer. 

The company was founded in 2014 and is headquartered in Somerset, New Jersey. Legend Biotech now employs over 2,400 people across six global manufacturing sites. Two of these sites are in Ghent: Obelisc (Technology Park Zwijnaarde) and Tech Lane (Eilandje Zwijnaarde). 

In Ghent, Legend Biotech focuses on the production of advanced CAR-T cell therapies for the treatment of multiple myeloma, in close collaboration with Johnson & Johnson.