As a Quality Person in Plant (QPIP), you provide quality oversight over the production of personalized cell therapies, supporting both clinical and commercial operations in a sterile GMP environment. This role combines scientific understanding with strong interpersonal skills and a keen eye for detail.
As a QPIP, you will work daily in our sterile GMP environment, supporting the production of personalized cell therapies. You combine process knowledge with a strong quality mindset to ensure that every step meets our high standards.
- Quality oversight in the cleanroom (on-the-floor witnessing): You support operators during cell therapy manufacturing by being physically present on the shop floor ("on-the-floor witnessing"). You act as the first point of contact for operators on quality, process discipline, and documentation. You guide them in resolving production issues and ensure that any concerns are escalated in a timely and appropriate manner by involving the right stakeholders. You monitor compliance with procedures in real time and ensure that all interventions are carried out correctly and in line with GMP requirements.
- Compliance & Quality Assurance: You perform periodic quality checks and audits related to processes, documentation, and manufacturing activities. You proactively promote compliance to reduce non-conformities and deviations within the supported areas.
- Batch Review & Escalation: You review production procedures and batch records and take the lead in the operational batch release process. You identify deviations, assess their impact, and escalate where necessary in line with quality guidelines, always prioritizing patient safety and compliance.
- Deviations & Documentation: You support the logging, investigation, and assessment of deviations, CAPAs, change controls, and complaints. You review process documentation to support unit operations and release activities.
- You perform your activities in full compliance with saftey policies, quality systems, and cGMP requirements. You take on additional responsibilities when needed to ensure quality standards are maintained across the facility.
- A minimum of a bachelor's degree in Life Sciences or equivalent relevant experience in the pharmaceutical or biotech industry.
- Preferably at least 2 years of relevant experience in an aseptic manufacturing environment within pharma or biotech.
- Fluent English (written and spoken) is required
- Knowledge of Dutch is an asset
- You work in a structured and detail-oriented way and follow procedures with care and accuracy.
- You make well-considered decisions and are able to think creatively while maintaining compliance and quality standards.
- You are solution-oriented and handle challenges in a constructive and communicative manner.
- You communicate clearly and adapt your message to your audience, both verbally and in writing.
- Knowledge of cGMP regulations and FDA/EU guidelines related to the manufacturing of cell-based products, as well as Good Tissue Practices.
- Ability to summarize and present results, with strong teamwork skills.
- Ability to assess the criticality of issues and communicate complex matters effectively to management.
- A meaningful job with an excellent work-life balance. You will work 4 days. After that you will enjoy 4 days off. This position operates within our future (rotating) night shift system. Please be prepared to work across various shifts starting from 6AM and ending by 2AM as well as our night shifts ranging from 6PM until 4 AM and 8 PM until 6AM. While night shifts are not currently in place, employees hired for this role should be willing and able to work within the (rotating) night shift system once implemented.
- 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 permanent contract of indefinite duration and an attractive salary package complemented by a wide range of fringe benefits, including additional statutory holidays, meal vouchers, company laptop, net allowance, group and hospitalization insurance, double holiday pay, end-of-year bonus, performance bonus and the possibility to participate in our bicycle lease plan.
- Many fun and informal events.
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.
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.
You can find more information about how we collect, use, and protect your personal data for recruitment purposes, including your rights under applicable data protection laws, in our Candidate Privacy Notice here: https://legendbiotech.eu/en/candidate-privacy-notice (Dutch: https://legendbiotech.eu/nl/candidate-privacy-notice).
