IT Quality & CSV Manager – Cell Therapy

Qabird; Leiden; Hybrid; EUR 65,000 - 85,000; Full time

Benefits offered by this job

Competitive benefits

Opportunities for career growth

Balanced work environment

Job summary

Qabird in Leiden is looking for a Manager, IT Quality and Computerized Systems Validation to lead the CSV function at the Leiden Cell Therapy Facility. You will manage CSV activities, participate in regulatory audits, and ensure compliance with industry standards.

The ideal candidate has a Bachelor’s degree in engineering or IT and at least 5 years of experience in a biotech manufacturing environment. This hybrid role offers opportunities to work in a dynamic and impactful setting.

Qualifications

• Minimum 5+ years of relevant industry experience.
• Experience with IT Quality & Compliance applications in bio-tech.
• Demonstrated success in a high-performing environment.

Responsibilities

• Manage computerized system validation activities and projects.
• Act as CSV Subject Matter Expert for IT/compliance matters.
• Participate in regulatory audits as Digital Plant representative.

Skills

Computerized systems validation

IT Quality & Compliance

Regulatory knowledge (GxP)

Project management

Education

Bachelor’s in engineering, IT, or Science

Tools

Change Management system (Infinity)

Manufacturing Execution Systems (MES)

Quality Management Systems (LIMS, QMS)

Enterprise Resource Planning (ERP)

Job description

Qabird in Leiden is looking for a Manager, IT Quality and Computerized Systems Validation to lead the CSV function at the Leiden Cell Therapy Facility. You will manage CSV activities, participate in regulatory audits, and ensure compliance with industry standards.

The ideal candidate has a Bachelor’s degree in engineering or IT and at least 5 years of experience in a biotech manufacturing environment. This hybrid role offers opportunities to work in a dynamic and impactful setting.