Qa operations team lead Vacatures

Over de vacature

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:

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? Apply now.

Over de vacature

Overview

In this role you drive the strategic quality oversight of external contract testing laboratories and cell banking operations to ensure GLP/GMP compliance, patient safety, and regulatory readiness. You lead a global quality function, partnering with external labs to protect product integrity and enable reliable launches. You will shape risk-based oversight, resolve quality issues, and mentor a high-performing team in a complex, regulated environment. This is a chance to influence quality governance across the contract testing network and accelerate remediation as needed.

Arbeidsvoorwaarden / Benefits

• medical, dental, vision insurance
• retirement benefits (401(k
• paid holidays
• vacation and sick days
• flexible benefits package
• compensation with bonus/long-term incentives (where applicable)

Verantwoordelijkheden

• Lead strategy, organisation design, budget oversight and performance management for CTLs and cell bank quality oversight
• Establish a risk-based quality oversight model for CTLs and for cell banking
• Provide operational leadership for drug substance, drug product and finished product testing
• Oversee quality compliance of CTLs with regulatory expectations and GLP/GMP requirements
• Oversee quality issues, OOS investigations, and deviations impacting launch or supply continuity
• Lead analytical technology transfer quality oversight
• Define performance metrics and governance routines to monitor quality and operations
• Lead quality assessments for prospective CTLs or new method candidates and remediate gaps
• Establish and maintain quality agreements to protect company quality and compliance
• Direct, mentor, and develop a high-performing QA team dedicated to external testing oversight
• Foster a culture of accountability, collaboration, operational excellence, and proactive problem-solving across internal and external networks

Belangrijkste vereisten

• Minimum of ten (10) years in Quality Systems/QA/QC within pharmaceutical manufacturing under global GMP and health authority requirements

• Proven track record managing complex quality investigations, risk assessment, and data-driven decisions

• Strong compliance background with experience supporting regulatory inspections and health authority interactions

• Demonstrated success leading and developing teams

• Ability to travel 30% of the time, including short-notice travel

• leadership and people development

• collaboration and cross-functional influence

• problem-solving and decision-making

• quality governance models

• supplier oversight and risk-based quality management systems

• external partner leadership (biologics/vaccines)

Over de vacature

Overview

In this role you lead the site's quality management system and daily quality operations to ensure ISO 9001 compliance and superior product quality. You work hands-on on the shop floor, partnering with Production, Logistics, and Leadership to embed quality in daily operations. You act as the Quality System Management Representative and primary liaison for customers and external auditors, driving continuous improvement and risk management. This position offers scope to shape quality strategy, enhance efficiency, and support global quality objectives.

Arbeidsvoorwaarden / Benefits

• flexible working hours
• competitive salaries
• learning opportunities and internships

Verantwoordelijkheden

• Direct the quality assurance function across departments to meet organizational goals
• Shape site QA program strategy and ensure regulatory compliance for processes, products, and markets
• Collaborate with Senior Leadership to deliver safety, quality, and process excellence while supporting growth
• Promote and embody Merit HEART program values in decision making
• Identify opportunities to improve systems, reduce cost, and enhance customer satisfaction
• Provide guidance on disposition of non-conforming products and initiate preventive actions
• Coordinate Emergency Management Team activities and oversee product investigations
• Oversee onboarding of new products/technologies and ensure smooth operations transitions
• Mentor and manage performance of QA staff; plan training and career development
• Provide technical support for existing products and new product transfers
• Maintain on-floor visibility to monitor processes and identify quality risks
• Prepare and review procedures and documentation for testing/manufacturing processes
• Lead verification and validation activities and support external inspections/audits
• Manage resources and projects within the QA team

Belangrijkste vereisten

• Bachelor's degree in Quality Engineering/Engineering/Science or equivalent (NFQ Level 7+)

• At least nine years of related experience with minimum four years in a management role

• Proven track record in leading organizations through external inspections/audits (FDA, Notified Bodies, regulatory authorities, customers)

• Working knowledge of U.S. FDA, MDR EU 2017/745, ISO 13485, ISO 14971, CMDR, ANVISA, TGA, JPAL/JGMP

• Strong communication skills in English and local language

• Computer skills with standard office software and ability to learn specialized software

• Understanding of medical device industry and Merit's product applications

• Postgraduate diploma/Master's in Quality Management preferred

• Lean and Six-Sigma process-improvement aptitude preferred

• Experience in medical device manufacturing management preferred

• Proven leadership of large, international teams across regions preferred

• strong leadership and team management

• excellent communication and collaboration

• problem-solving and decision-making

• ISO 9001 Quality Management System

• FDA regulatory knowledge

• MDR EU 2017/745 understanding