GMP Investigations Specialist - Cell & Gene Therapy

MindCapture BV; Oost-Vlaanderen; On-site; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Meal vouchers

Eco vouchers

DKV health insurance

Group insurance

Net expense allowance

Company car

Personalised training and development

Job summary

MindCapture BV is seeking a highly skilled MSAT professional to own GMP investigations and strengthen manufacturing processes in a life sciences setting. You will lead root cause analyses, CAPA implementations, and support regulatory inspections across cell and gene therapy manufacturing.

The role requires strong technical communication, collaboration with Quality, Engineering and Operations, and deep knowledge of GMP, process validation, and continuous improvement.

Qualifications

• Experience leading GMP manufacturing investigations.
• Experience with root cause analysis and CAPA implementation.
• Experience supporting GMP regulatory inspections and compliance activities.
• Understanding of process robustness, process validation and manufacturing operations.
• Experience with deviations, investigations, CAPAs and quality management systems.
• Strong technical and interpersonal communication skills.
• Full professional proficiency in English.
• Dutch language skills are considered an advantage.

Responsibilities

• Define investigation strategies and drive root cause identification.
• Support CAPA implementation related to manufacturing processes.
• Maintain process knowledge and oversight of cell and gene therapy manufacturing processes.
• Troubleshoot complex scientific and technical manufacturing issues.
• Support regulatory inspections and investigation related responses.
• Apply risk assessment methodologies and assess product quality impact.
• Identify recurring deviations, analyse trends and support process improvements.
• Support technical feasibility studies for manufacturing technologies and automation.
• Collaborate with Manufacturing, Quality, Engineering, Supply Chain and other functions.
• Support process validation, technical transfer and manufacturing operations.

Skills

GMP investigations

Root cause analysis

CAPA implementation

Cell and gene therapy manufacturing

Regulatory inspections

Quality management systems

Process validation

Cross-functional collaboration

English proficiency

Dutch advantage

Job description

MindCapture BV is seeking a highly skilled MSAT professional to own GMP investigations and strengthen manufacturing processes in a life sciences setting. You will lead root cause analyses, CAPA implementations, and support regulatory inspections across cell and gene therapy manufacturing.

The role requires strong technical communication, collaboration with Quality, Engineering and Operations, and deep knowledge of GMP, process validation, and continuous improvement.