QA Operations CGT Teamlead

• 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.

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.

QA Operations CGT Teamlead

• 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.

Geleen, The Netherlands