QA Operations CGT Teamlead

Lonza; Geleen; Vor Ort; Confidential; Vollzeit

Benefits dieser Stelle

Agile culture

Inclusive workplace

Performance-based pay

Role/location benefits

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Team leadership

Quality Assurance

cGMP knowledge

Regulatory knowledge

English fluency

Ausbildung

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

Jobbeschreibung

QA Operations CGT Teamlead

Geleen, The Netherlands

As a QA Operations Team Lead at Lonza in Geleen, you will lead and develop a team of Quality Assurance professionals supporting our Cell & Gene Therapy (CGT) manufacturing operations. You will combine people leadership with hands‑on quality expertise to ensure compliant operations and support the successful release of life‑changing therapies.

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.

Ready to shape the future of life sciences?