Commissioning & Qualification Supervisor

Job Description

Legend Biotech is seeking a Commissioning & Qualification Supervisor to join the CAR-T Asset Management team in Ghent, Belgium. This role involves leading and overseeing day-to-day C&Q activities within the cGMP Clinical and Commercial Cell Therapy Manufacturing plants. The supervisor will manage protocol execution, user access, and system quality reviews for CAR-T process and lab equipment, ensuring safe and compliant manufacturing operations. Responsibilities:

• Leading and overseeing day-to-day C&Q activities.
• Managing multiple and complex C&Q projects.
• Developing, leading & coaching a team of C&Q Engineers.
• Planning, execution, tracking and reporting of status and risks/issues associated with C&Q activities.
• Supporting in authoring CARA documents, T&TM’s, Periodic Qualifications, Project Plans, Master Plans, and PSQR’s.
• Supporting in execution of commissioning, qualification, requalification and any associated engineering activities within the plants.
• Supporting and/or owns technical investigations detected during C&Q activities.

Requirements:

• A minimum of a Master’s Degree in Science, Engineering, Bioengineering or equivalent technical discipline is required.
• A minimum of 3 years relevant C&Q and people oriented work experience within a cGMP environment.
• Detailed knowledge and understanding of cGMP, FDA/EU and Industry regulations, standards, guidance and expectations.
• Proven people management skills.
• Strong interpersonal and written/oral communication skills.
• Proficient in applying process excellence and QRM tools and methodologies.
• Dutch/English language skills.

The role offers:

• Opportunity to work within the CAR-T Asset Management team.
• Chance to lead and oversee C&Q activities in a cGMP environment.
• Professional development through coaching and team leadership.