CGT QA Operations Team Lead — Quality & Compliance

Lonza; Geleen; On-site; Confidential; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Performance-based pay

Role/location benefits

Job summary

Lonza Geleen, The Netherlands, is seeking a QA Operations CGT Team Lead to guide a team of QA professionals in CGT manufacturing, ensuring compliant operations and timely product disposition.

The role combines people leadership with hands-on quality expertise, overseeing batch record review, CAPA, change controls, audits, and continuous improvement, while collaborating with manufacturing, regulatory affairs, and supply chain.

Qualifications

• Bachelor’s or master’s degree in a relevant scientific discipline (biotechnology/biochemistry/pharmacy/chemistry).
• At least five years QA experience in a cGMP environment, including ≥2 years in a leadership role.
• Strong understanding of CGT manufacturing processes and quality requirements.
• In-depth knowledge of cGMP regulations (FDA/EMA) and QA systems.
• Proven ability to lead and develop a team with strong communication and English skills.
• Strong analytical, planning and decision-making skills with prioritization ability.
• Experience with electronic quality management systems is preferred.

Responsibilities

• Lead, coach and develop a team of QA professionals with clear objectives and performance feedback.
• Plan and oversee daily QA Operations activities: batch record review, deviations, CAPA, change controls, and disposition support.
• Ensure documentation and manufacturing activities comply with cgmp and Lonza standards.
• Act as primary QA contact for CGT operations and collaborate across manufacturing, regulatory and supply chain.
• Lead quality investigations, root cause analysis and risk assessments with timely CAPA implementation.
• Monitor quality performance metrics, identify trends and drive continuous improvement.
• Support internal and external audits and regulatory inspections with timely responses.

Skills

Team leadership

Quality Assurance

cGMP knowledge

Regulatory knowledge

English fluency

Education

Bachelor's or Master's in biotechnology / biochemistry / pharmacy / chemistry

Job description

Lonza Geleen, The Netherlands, is seeking a QA Operations CGT Team Lead to guide a team of QA professionals in CGT manufacturing, ensuring compliant operations and timely product disposition.

The role combines people leadership with hands-on quality expertise, overseeing batch record review, CAPA, change controls, audits, and continuous improvement, while collaborating with manufacturing, regulatory affairs, and supply chain.