QS Reviewer

Johnson & Johnson; Gent; Sur place; EUR 83 000 - 131 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine in Belgium seeks a QS Reviewer to independently review nonconformities and CAPAs for CAR-T BE operations across Obelisc Ghent, Tech Lane Ghent, QC Beerse and cCPC Beerse. You will coach investigation teams on how to assess and document quality investigations in line with procedural requirements.

The role requires a Master Scientific degree, strong knowledge of cGMP and ICH guidelines, 5+ years in Quality Systems, fluent English, and experience coaching

Qualifications

• Master level degree with a technical specialization in analytics, chemistry, biotechnology, pharmaceutical sciences or engineering.
• Strong knowledge of cGMP, ICH guidelines, policies, standards and procedures.
• Min. 5 years of experience in Quality Systems or Quality Assurance related to manufacturing.
• Good knowledge of cGMP regulations related to sterile manufacturing.
• Solid understanding of Quality Systems processes, specifically nonconformity and CAPA handling.
• Fluent knowledge of English.
• Experience coaching personnel on investigation practices.
• Familiarity with systems such as COMET, Truvault, SUMMIT and MS Office.

Responsabilités

• As part of the Quality Systems team, you will drive compliance and high-quality standards across CAR-T operations.
• This will involve:
• Review nonconformity risk assessments and CAPA end-to-end investigations according to the requirements stipulated in global and local procedural documents.
• Collaborate with investigation teams and Quality members to ensure risk assessments and investigations are conducted and documented in a proper manner.
• Coach personnel involved in the Nonconformity and CAPA handling process on good investigational practices.
• Collaborate with Quality Systems team members and process stakeholders to ensure reviews are conducted in a timely manner.
• Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Monitor compliance with legal requirements together with the SHE department and actively contribute to safety and environmental prevention.

Connaissances

Analytical thinking

Structured communication

Coaching mindset

Fluent English

cGMP knowledge

Investigation coaching

Quality Systems familiarity

Formation

Master's degree in analytics/chemistry/biotechnology/pharmaceutical sciences/engineering

Outils

COMET

Truvault

SUMMIT

MS Office

Description du poste

• Duration of the contract: Until 31 December 2026

Imagine your next project supporting groundbreaking CAR-T cell therapy manufacturing to deliver life-changing quality governance and support across state-of-the-art facilities.

The QS Reviewer is responsible for the independent review of nonconformities and CAPAs managed by the CAR-T BE organization. In this role, you will coach investigation teams on how to assess and document quality investigations in line with procedural requirements, supporting Belgian facilities across Obelisc Ghent, Tech Lane Ghent, QC Beerse, and cCPC Beerse.

roles and responsibilities

As part of the Quality Systems team, you will drive compliance and high-quality standards across CAR-T operations.

This will involve:

• Review nonconformity risk assessments and CAPA end-to-end investigations according to the requirements stipulated in global and local procedural documents.
• Collaborate with investigation teams and Quality members to ensure risk assessments and investigations are conducted and documented in a proper manner.
• Coach personnel involved in the Nonconformity and CAPA handling process on good investigational practices.
• Collaborate with Quality Systems team members and process stakeholders to ensure reviews are conducted in a timely manner.
• Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Monitor compliance with legal requirements together with the SHE department and actively contribute to safety and environmental prevention.

how to succeed

You bring strong analytical thinking, structured communication, and a practical coaching mindset to ensure seamless quality operations under daily supervision.

You will also bring:

• Master Scientific degree with a technical specialization in analytics, chemistry, biotechnology, pharmaceutical sciences, or engineering (or equivalent through experience).
• Good knowledge of cGMP, ICH guidelines, policies, standards, and procedures.
• Min. 5 years of experience in Quality Systems or Quality Assurance related to manufacturing.
• Good knowledge and understanding of cGMP regulations related to sterile manufacturing.
• Solid understanding of Quality Systems processes, specifically nonconformity and CAPA handling.
• Fluent knowledge of English.
• Experience in coaching personnel on investigation practices.
• Familiarity with systems such as COMET, Truvault, SUMMIT, and MS Office.

This role offers a very competitive hourly rate. This contract will run until 31 December 2026.

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas - Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong".