QPIP (Quality Person in Plant)

Legend Biotech; Gent; Sur place; EUR 45 000 - 65 000; Plein temps

Avantages offerts par ce poste

4-day work week

Meal vouchers

Hospitalization insurance

Performance bonus

Résumé du poste

Legend Biotech in Gent, Belgium is looking for a Quality Person in Plant (QPIP) to oversee clinical and commercial production of personalized cell therapies in a GMP environment. The ideal candidate should have a minimum of a Bachelor’s degree in Life Sciences and at least 2 years of relevant experience in an aseptic manufacturing setting.

This role emphasizes compliance, collaboration and strong communication skills, promoting a quality-driven environment. Benefits include a unique 4-day work week, and a comprehensive salary package including various allowances and bonuses.

Qualifications

• Minimum of a bachelor’s degree in Life Sciences or equivalent relevant experience.
• Preferably at least 2 years of relevant experience in an aseptic manufacturing environment.
• Structured detail-oriented with decision-making capability.

Responsabilités

• Provide quality oversight during manufacturing.
• Guide operators in resolving production issues.
• Monitor compliance with procedures and perform quality checks.

Connaissances

Aseptic manufacturing experience

Fluent English

Knowledge of Dutch

Knowledge of cGMP regulations

Teamwork skills

Formation

Bachelor's degree in Life Sciences

Description du poste

Job Overview

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.

Responsibilities

• Notifies operators on quality, process discipline, and documentation; provides on-the-floor witnessing during manufacturing.
• Guides operators in resolving production issues and escalates concerns timely and appropriately.
• Monitors compliance with procedures in real time and ensures interventions follow GMP requirements.
• Performs periodic quality checks and audits related to processes, documentation, and manufacturing activities.
• Proactively promotes compliance to reduce nonconformities and deviations.
• Reviews production procedures and batch records, leading operational batch release.
• Identifies deviations, assesses impact, and escalates when necessary, prioritizing patient safety and compliance.
• Supports logging, investigation, and assessment of deviations, CAPAs, change controls, and complaints.
• Reviews process documentation to support unit operations and release activities.
• Works in full compliance with safety policies, quality systems, and cGMP requirements; takes on additional responsibilities as needed.

Qualifications

• 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.
• Structured and detail-oriented with the ability to follow procedures accurately.
• Ability to make well-considered decisions and think creatively while maintaining compliance.
• Solution-oriented, handling challenges constructively and communicatively.
• Clear communication skills, adapting messages to diverse audiences, both verbally and in writing.
• Knowledge of cGMP regulations and FDA/EU guidelines related to cell-based product manufacturing, and Good Tissue Practices.
• Strong teamwork skills, summarizing and presenting results effectively.
• Ability to assess the criticality of issues and communicate complex matters effectively to management.

Benefits

• Meaningful work with an excellent work-life balance: a 4‑day work week followed by 4 days off.
• Supportive and innovative work environment that values learning and personal development.
• Opportunity to work with colleagues worldwide.
• Permanent contract with an attractive salary package and 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 a bicycle lease plan.
• Frequent fun and informal events.

Equal Employment Opportunity

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.

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