Quality Person In Plant

As a Quality person in plant (QPIP) you assist in providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. The role combines scientific knowledge with people skills and eye for detail.

What can you expect?

• Serves as a Quality person in plant in support of cell therapy manufacturing.
• Ensures Quality Oversight in plant covering various process related activities
• Performs periodic Quality checks/audits related to process, documentation and process manipulations
• Strive to reduce non-conformances and deviations in supported areas by proactively driving compliance.
• Responsible for real time review of process documentation in support of process unit operations and release activities where needed.
• Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
• Supports in accurate and timely input, investigation and review of manufacturing deviations, CAPAs, change controls and complaints.
• Review and approve manufacturing procedures and batch records
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Support regulatory inspections and audits by ensuring inspection readiness within facility.
• Perform internal housekeeping audits.
• Other duties will be assigned, as necessary.

Who are we looking for?

Education

• A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required or relevant years of experience within the pharmaceutical industry.

Experience

A minimum of 2 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A minimum of 2 years of experience with quality support in clinical manufacture is preferred.

Languages

• English at a fluent level is a must have for this role, fluency in Dutch is an advantage.

Strengths

• Great attention to detail and ability to follow the procedures.
• Strong decision-making ability and think creatively while maintaining compliance and quality.
• Ability to manage conflict and issues that arise with internal or external customers.
• Good written and verbal communication skills are required.

Expertise

• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
• Ability to summarize and present results, and experience with team-based collaborations is a must. 
• Must be able to discern the criticality of issues and to communicate to management regarding complex issues.

What do we offer you?

• A meaningful job with an excellent work-life balance. You will work 4 days, followed by 4 days off.
• A supportive and innovative work environment. We value and encourage learning and personal development.
• The opportunity to work with people from different departments & regions.
• 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.

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.