CGT QA Operations Team Lead

Lonza Group Ltd.; Geleen; On-site; EUR 54,000 - 76,000; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Performance-based compensation

Benefits by role/location

Job summary

Lonza Group Ltd. Geleen, The Netherlands is seeking a QA Operations CGT Teamlead to lead a team of QA professionals and drive quality in CGT manufacturing, batch records, deviations and CAPA while fostering a culture of accountability.

You will plan daily QA operations, ensure cGMP compliance, support audits, and act as the primary QA contact across manufacturing, supply chain and regulatory affairs, delivering timely investigations and data-driven improvements.

Qualifications

• Bachelor's or Master's in a relevant scientific discipline.
• At least 5 years of QA experience in a cGMP environment, including 2+ years in leadership.
• Strong understanding of Cell and Gene Therapy manufacturing processes and their quality requirements.
• In-depth knowledge of cGMP regulations and quality management systems (FDA/EMA).
• Proven ability to lead, motivate and develop a team with strong communication skills.
• Fluency in written and spoken English.

Responsibilities

• Lead, coach and develop a team of QA professionals; set objectives, provide training, and drive performance.
• Plan and oversee daily QA Operations activities (batch record review, deviations, CAPA, change controls) and support disposition of materials and finished products.
• Ensure compliance with cGMP and Lonza's quality standards; adhere to internal procedures and regulatory expectations.
• Act as a primary QA contact for CGT manufacturing operations; collaborate with manufacturing, supply chain, regulatory affairs and other departments.
• Lead investigations, root cause analysis and risk assessments with timely corrective actions.
• Monitor quality performance metrics, identify trends, and drive continuous improvement in QA Operations and CGT processes.
• Support internal and external audits and regulatory inspections, ensuring timely responses.

Skills

Leadership

Quality Assurance

cGMP knowledge

Regulatory knowledge (FDA/EMA)

English fluency

Analytical skills

CAPA

Process improvement

Team management

Education

Bachelor's or Master's in science

Tools

eQMS

Job description

Lonza Group Ltd. Geleen, The Netherlands is seeking a QA Operations CGT Teamlead to lead a team of QA professionals and drive quality in CGT manufacturing, batch records, deviations and CAPA while fostering a culture of accountability.

You will plan daily QA operations, ensure cGMP compliance, support audits, and act as the primary QA contact across manufacturing, supply chain and regulatory affairs, delivering timely investigations and data-driven improvements.