QPIP Supervisor

As a Quality Person In Plant  Supervisor (QPIP Supervisor) you lead, train and support the full QPIP team. You combine your scientific knowledge with people and decision making capabilities.

What can you expect?

• You supervise the direct QPIP team (+-8 people) and ensure workload is distributed correctly.

• You optimize the way of working within the team and ensure we are able to focus on the right issues.

• You take the full responsibility to ensure the team gets guidance, feedback and recurrent 1-1 meetings with you. You help them improve and support changes in the way of working.

• You are responsible for the personal development, performance evaluation and setting clear objectives for the team.

• You ensure quality oversight in CAR-T aseptic manufacturing plant, real-time review of batch records

• Support investigation of deviations, evaluation CAPA’s, change controls and complaints.

• Support internal / external audits, accountable for audit readiness within the QPIP team.

• Reads, interprets, reviews, and approves SOPs/WIs as QPIP SME

• You ensure streamlined processes, correct documentation and audit readiness.

• You act as the SPOC for the QPIP team and take decisions on  solutions for GMP issues.

Who are we looking for?

Education

• A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.

Experience

• A minimum of 3 years relevant work experience is required, within a quality assurance or similar field. It’s a strong advantage if you have experience within cell therapy or the biotech industry.

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.

• Strong coaching and development mindset to let talent develop and grow.

 

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.