Deviation Specialist

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

About This Vacancy

As a Deviation Specialist in the Biotechnology industry:

• You are responsible for the quality investigation process, educate the organization on effective investigation handling, and drive root cause analysis for timely product release.
• You oversee and support the implementation of CAPAs related to the manufacturing process, ensuring compliance and continuous improvement.
• You act as the main support during Regulatory Authorities inspections, defend investigation strategies, and maintain inspection readiness.
• You maintain robust process knowledge of cell and gene therapy manufacturing, support technical transfer, and troubleshoot scientific/technical problems.
• You identify improvement opportunities, and support the implementation of new technologies to enhance manufacturing processes.
• You build strong partnerships with internal and external stakeholders to ensure efficient execution of process validation, production schedules, and seamless knowledge transfer.

About This Vacancy

As a Deviation Specialist in the Biotechnology industry:

• You are responsible for the quality investigation process, educate the organization on effective investigation handling, and drive root cause analysis for timely product release.
• You oversee and support the implementation of CAPAs related to the manufacturing process, ensuring compliance and continuous improvement.
• You act as the main support during Regulatory Authorities inspections, defend investigation strategies, and maintain inspection readiness.
• You maintain robust process knowledge of cell and gene therapy manufacturing, support technical transfer, and troubleshoot scientific/technical problems.
• You identify improvement opportunities, and support the implementation of new technologies to enhance manufacturing processes.
• You build strong partnerships with internal and external stakeholders to ensure efficient execution of process validation, production schedules, and seamless knowledge transfer.

What We Expect From You

• You have a Master’s degree in Science, Pharmacy, Engineering.
• You have experience in a cGMP environment in Pharma/Biotech industry.
• You have experience with FDA/EU regulations related to ATMP’s.
• Scientific writing and organizational skills are your strong points.
• You combine an analytical mindset and great communication skills to be able to problem solve.
• Fluent in Dutch and English.

What You Can Expect From Us

TMC is an international high-tech consultancy company that brings expertise to its clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients and we help them to be more competitive in an ever more global and faster-changing technological world. At TMC we believe that people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive in. We offer you a challenging and stimulating work environment in which you can be the director of your own career. As an Employeneur you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.