QA Operations CGT Teamlead

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

QA Operations CGT Teamlead

Geleen, The Netherlands

What you will get

The full-time annual base pay for this position in The Netherlands is expected to range between €54.000 and €75.600. Initial salary placement within this range will be determined based on role-related factors such as experience, qualifications, and expected contribution.

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• A variety of benefits dependent on role and location.
• The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits.

What you will do

• Lead, coach and develop a team of QA professionals through clear objectives, training and regular performance feedback, support recruitment and promote a culture of quality, accountability and continuous improvement.
• Plan and oversee daily QA Operations activities, including batch record review, deviations, corrective and preventive actions (CAPA), change controls and quality activities supporting the disposition of raw materials, in-process materials and finished products, providing hands-on support when needed.
• Ensure quality documentation and manufacturing activities comply with current Good Manufacturing Practice (cGMP), applicable regulations, quality agreements, internal procedures and Lonza's global quality standards.
• Act as a primary QA contact for CGT manufacturing operations, providing guidance on quality matters and escalations and working closely with manufacturing, supply chain, regulatory affairs and other departments.
• Lead and support quality investigations, root cause analysis and risk assessments, ensuring effective corrective and preventive actions are implemented within agreed timelines.
• Monitor and present quality performance metrics, identify trends and drive continuous improvement within QA Operations and CGT manufacturing processes.
• Support internal and external audits and regulatory inspections, ensuring timely and effective responses to findings.

What we are looking for

• A bachelor's or master's degree in a relevant scientific discipline, such as biotechnology, biochemistry, pharmacy or chemistry.
• At least five years of Quality Assurance experience in a cGMP-regulated environment, including at least two years in a leadership or supervisory role.
• Strong understanding of Cell and Gene Therapy manufacturing processes and their associated quality requirements.
• In-depth knowledge of cGMP regulations, including relevant FDA and EMA requirements, and quality management systems.
• Proven ability to lead, motivate and develop a team, with strong communication, interpersonal and presentation skills and fluency in written and spoken English.
• Strong analytical, problem-solving, planning and decision-making skills, with the ability to manage changing priorities and deliver results within agreed timelines.
• Experience with electronic quality management systems is preferred.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.