Deviation Specialist: Quality Investigator & CAPA Leader

TMC; Oost-Vlaanderen; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

TMC, an international high-tech consultancy, seeks a Deviation Specialist in Belgium to lead quality investigations and CAPA programs within cell and gene therapy manufacturing. You will support regulatory inspections and drive continuous improvement across production and tech transfer, collaborating with internal and external stakeholders.

Qualified candidates hold a Master’s degree in Science, Pharmacy, or Engineering and have strong analytical and communication skills, with fluency in Dutch

Qualifications

• Master’s degree or higher in Science, Pharmacy, Engineering.
• Experience in a cGMP environment in Pharma/Biotech.
• Experience with FDA/EU regs related to ATMPs.
• Scientific writing and organizational skills.
• Analytical mindset and strong communication for problem solving.
• Fluent in Dutch and English.

Responsabilités

• Own the quality investigation process and educate the organization on effective handling; drive root cause analysis for timely product release.
• Oversee and support CAPA implementation related to manufacturing processes, ensuring compliance and continuous improvement.
• Act as main support during Regulatory Authority inspections; defend investigation strategies and maintain inspection readiness.
• Maintain robust process knowledge of cell and gene therapy manufacturing; support tech transfer and troubleshoot problems.
• Identify improvement opportunities and support new technology implementations to enhance manufacturing processes.
• Build strong partnerships with internal and external stakeholders to enable execution of process validation, production schedules, and knowledge transfer.

Connaissances

Quality investigations

CAPA management

Regulatory inspections

Analytical mindset

Strong communication

Formation

Master’s degree in Science/Pharmacy/Engineering

Description du poste

TMC, an international high-tech consultancy, seeks a Deviation Specialist in Belgium to lead quality investigations and CAPA programs within cell and gene therapy manufacturing. You will support regulatory inspections and drive continuous improvement across production and tech transfer, collaborating with internal and external stakeholders.

Qualified candidates hold a Master’s degree in Science, Pharmacy, or Engineering and have strong analytical and communication skills, with fluency in Dutch