Qc team lead Vacatures

Over de vacature

QC Team Lead

Geleen, The Netherlands

Lead a Quality Control team that supports manufacturing through reliable testing and monitoring of the production environment and critical operations. In this role, you will develop your team and ensure timely, high-quality results, with product quality and patient safety at the heart of your work.

What you will get:

• A gross annual salary between EUR 54,000 and EUR 75,600, depending on your experience and qualifications.
• 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 your team, ensuring appropriate training and qualification while promoting collaboration, accountability and professionalism.
• Plan and coordinate QC testing, including routine environmental monitoring and monitoring during critical manufacturing operations, to deliver accurate results within agreed timelines.
• Review and approve assay results, documentation and quality events within your area of responsibility, ensuring deviations from established procedures are identified and addressed.
• Work closely with Manufacturing, project leads and other QC teams to align priorities, establish realistic timelines for new methods and method transfers, and ensure effective handovers between teams and shifts.
• Resolve operational challenges, troubleshoot testing and performance issues, and address personnel matters and workplace conflicts.
• Lead or oversee projects and continuous improvement initiatives, and ensure relevant testing data is captured, analysed and reported to identify trends.
• Maintain a safe working environment by ensuring safety procedures are understood and followed, equipment and work areas are safe, and staffing needs are supported by workload assessments.

What we are looking for:

• Relevant experience in Quality Control within a regulated manufacturing or laboratory environment.
• Experience leading, coaching or coordinating a team, with the ability to support development and manage performance.
• Understanding of Good Manufacturing Practice (GMP), laboratory documentation and quality processes, including deviation management.
• The ability to plan testing activities, manage workloads and balance competing priorities, with willingness to work a five-shift rotation, including night shifts and weekends.
• Strong analytical and problem-solving skills, including experience interpreting testing results and identifying trends.
• Clear communication and collaboration skills, with the confidence to resolve conflicts and work effectively across teams.
• A commitment to safe working practices, reliable execution, product quality and patient safety.

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

Project Lead QC

Geleen, the Netherlands R80276

Bring people, priorities and projects together as a Project Lead Quality Control (QC) at Lonza in Geleen. With strong organizational and communication skills backed by technical understanding, you will connect customers and internal teams, coordinate technology transfers and help deliver life-changing cell and gene therapies.

What you will get:

• A gross annual salary between EUR 54'000 and EUR 75'600, depending on your experience.
• 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:

• Be a key QC contact for customers, building trust, aligning expectations and sharing clear updates on testing, technology transfers and project milestones.
• Proactively connect stakeholders across QC, Manufacturing and project management, bringing the right people together and driving decisions and follow-up.
• Lead and coordinate QC technology transfers and new method introductions, drawing on technical experts to support production campaigns and clinical and commercial readiness.
• Maintain project plans, coordinate training needs and keep activities on track through changing priorities, dependencies and challenging timelines.
• Prepare, review and/or approve method transfer plans, protocols, reports and assessments, supported by technical experts and the QC Manager.
• Coordinate QC input into change controls, deviations, investigations, validation and audit responses, alongside stability studies and reporting where applicable.
• Represent QC in internal and customer meetings, communicate progress and risks, and improve ways of working while maintaining current Good Manufacturing Practice (cGMP) compliance.

What we are looking for:

• Excellent organizational and planning skills, with the ability to manage competing priorities, adapt to change and deliver against tight timelines.
• Strong interpersonal and stakeholder management skills: you proactively reach out, build relationships and bring people together across a diverse team.
• Clear, confident communication in written and spoken English, with the ability to manage customer expectations and turn discussions into agreed actions.
• A technical or scientific background, supported by a bachelor's degree or equivalent in Biotechnology, Pharmaceutical Sciences or a related field, or comparable education and experience.
• Experience in pharmaceutical or biotechnology QC, including supporting or coordinating analytical method transfers.
• A working understanding of cell and gene therapy (CGT), cell culture and sterile manufacturing. You can follow technical discussions and bring in the right experts when deeper knowledge is needed.
• Experience supporting commercial projects would be an advantage, as would familiarity with biological assays such as flow cytometry, ELISA and PCR.

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

Principal Scientist Bioanalytics

Location: Geleen

As a member of the Analytical Development Team, you will be in charge of developing and running dedicated (Bio)analytical methods, while assisting with other ongoing developments, based on customer needs. You are responsible to ensure analytical development is in line with quality control. You are accountable for the performance and results of the assigned projects. Thereby you support and supervise new members of the group.

What you will get:

• 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 also found on

The full-time annual base pay for this position in The Netherlands is expected to range between 60.750,- EUR and 85.050,- EUR. Initial salary placement within this range will be determined based on role related factors such as experience, qualifications, and expected contribution.

What you will do:

• Transfer, optimize, and develop bioanalytical methods to support product development and quality control.
• Plan, execute, and document method pre-validation studies in accordance with applicable regulatory requirements.
• Authoring of Standard Operating Procedures (SOPs)
• Technical support in cross departmental documentation (validation documents, development documents)
• Train colleagues and transfer pre-validated methods to the GMP-compliant Quality Control (QC) department.
• Perform routine testing for development campaigns and stability studies as required.
• Represent the Analytical Development department as a Subject Matter Expert (SME) in interactions with internal stakeholders and external clients.
• Represent the Analytical Development department as a Subject Matter Expert (SME) and/or Project Team Member (PTM) in interactions with internal stakeholders and external clients.

What we are looking for:

• PhD + multiple years of experience in analytical development
• Expertise in analytical development of Bioassays in the area of mRNA-LNP.
• Practical and theoretical experience in analytical method development and validation, with a strong focus on potency assays in accordance with ICH and USP guidelines in the field of RNA-LNP bioassays. Especially regarding Flow Cytometry (FACS) and ELISA
• Deep understanding of statistical methods relevant to analytical method development and validation.
• Practical experience with cellular work (aseptic handling)
• Ability to lead junior staff and further their development
• Be a collaborative team player with a flexible and proactive mindset who thrives in a dynamic environment and views changing priorities as opportunities.
• Curiosity and enthusiasm for implementing and evaluating new analytical technologies.
• Very good communication skills and interaction with project organization and customers.

Preferred:

• Initial experience with GMP-compliant documentation and laboratory practices.
• Hands-on and deep theoretical experience with at least two of the following analytical techniques including trouble shooting: Sanger Sequencing, Oxford Nanopore Technology Sequencing, Quantitative PCR (qPCR), Liquid Chromatography coupled with Mass Spectrometry
• Initial experience in project management and/or customer management within an analytical development environment.

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

Job description:

As our Supervisor Quality Control (QC) Operations EM UM you are responsible for environmental and utility sampling and reporting and you will play a critical role in ensuring compliance of the utilities and environment in the manufacturing of pharmaceutical products.

As the leader of the Environmental Monitoring (EM) and Utilities Monitoring (UM) team, this role is responsible for guiding and developing both EM/UM staff and officers, fostering a culture of accountability, collaboration, and continuous improvement. A key part of the position involves providing performance feedback, conducting reviews, supporting employee development, and managing disciplinary processes when required.

The role ensures that all environmental and utility monitoring activities, including sampling and reporting, are carried out accurately, efficiently, and in accordance with established quality standards. It also oversees the maintenance and calibration of laboratory instrumentation, ensuring that equipment remains compliant and fit for purpose.

Working closely with cross-functional partners across Quality Assurance, Manufacturing, Product Support, and Production, this position plays a critical role in supporting product release activities, investigations, and operational excellence initiatives. In addition, the role contributes to the development, optimization, and validation of EM and UM methods, helping to ensure robust, accurate, and reproducible analytical processes.

A strong focus on regulatory compliance is essential. The position requires a thorough understanding of GxP principles and the application of key procedures related to deviations, out-of-specification results, documentation practices, and relevant ISO and Pharmacopoeia standards. Responsibilities also include reviewing documentation for compliance and ensuring that all activities are executed and reported according to regulatory and company requirements.

The role serves as a technical resource for the team, leveraging expertise in microbiological trending, data analysis, and troubleshooting to identify issues, drive investigations, and implement effective solutions. Technical challenges are addressed in alignment with established policies and procedures, ensuring operational continuity and quality compliance.

Beyond day-to-day operations, this position actively promotes continuous improvement across both the department and the wider site. This includes enhancing record-keeping practices, refining EM and UM processes, strengthening safety initiatives, and identifying opportunities for greater efficiency and effectiveness.

Leadership responsibilities also include conducting regular team meetings, communicating departmental priorities, tracking performance, and holding team members accountable for results. Additionally, the role supports the onboarding, orientation, and training of laboratory personnel, helping to build a knowledgeable and high-performing team committed to quality, compliance, and excellence.

Over de vacature

Overview

In this role you lead statistical strategy and execution for designated compounds/indications in early and late-stage programs. You engage with regulators, ensure consistent statistical methods across trials, and drive integrated data analyses to support development decisions. You contribute to trial design, analysis plans, and regulatory meetings, acting as a key scientific advisor within the CDT and trial teams. This position offers the chance to shape how Genmab advances pioneering antibody medicines that aim to transform patient outcomes. You will work in a collaborative, data-driven environment that values scientific rigor and impactful cancer therapy development.

Arbeidsvoorwaarden / Benefits

• 401(k) Plan: 100% match on the first 6% of contributions
• Health benefits: medical, dental, vision
• Paid time off: vacation, sick leave, holidays; discretionary parental leave
• Voluntary plans: critical illness, accident, hospital indemnity
• Backup care and family support programs
• Tuition reimbursement and Lifestyle Spending Account

Verantwoordelijkheden

• Act as lead and main Statistics contact for designated compound/indication
• Stay current with biostatistics developments and advise on innovative methodologies
• Engage with regulatory authorities on compound/indication level discussions
• Ensure consistency of statistical methods and data handling across trials
• Share compound/indication related work among biostatisticians and with vendors
• Support integrated database specification development with the programming team
• Provide statistical input to overall CDT strategy and synopsis development
• Advise on trial design, analyses, and advanced statistical techniques within CDT
• Represent CDT/company at regulatory meetings, KOLs, and partner meetings
• Drive design and synopsis development with stakeholders
• Ensure integrated databases availability and plan integrated analyses for development decisions
• Support development and communication related to presentations, posters, and articles
• Attend and present at meetings, congresses, and courses for professional networking
• Ensure biostatistician reviews of protocols, SAPs, results meetings, and trial reports
• Coordinate data transfers with partners alongside programmers and data managers
• Apply state-of-the-art statistical methods with solid scientific foundation
• Maintain proper documentation and oversee QC of vendor data and analyses
• Ensure trial work complies with Genmab SOPs, processes, and ICH-GCP
• Participate in regulatory data package discussions with Data Monitoring Committees
• Contribute to data integrity, transparency, and timely delivery of statistical deliverables

Belangrijkste vereisten

• Master's or PhD in statistics or a related field

• 8+ years of relevant experience preferred

• Experience in statistical analysis, modeling, simulation, and adaptive trial designs

• Biologics, targeted therapies, and companion diagnostics exposure preferred

• Experience with FDA, EMA, and ICH guidelines for statistics in drug development

• Experience with regulatory submissions (BLAs) and interactions with health authorities

• Proficiency with SDTM, ADaM, eSUB, and CDISC for regulatory submissions

• Track record of managing multiple complex projects in a technical role

• Proven ability to work with cross-functional teams and vendors

• Strong communication and leadership skills

• collaboration

• communication

• leadership

• statistical methods for drug development

• adaptive trial designs

• regulatory statistics

Over de vacature

Bedrijfsomschrijving:

Locatie: Zeewolde.
Deze organisatie is actief in de voedingsmiddelenindustrie en heeft meer dan 125 jaar ervaring. Vanuit de business lines Plant Based Food Solutions en Bakery Products biedt het bedrijf professionele klanten en consumenten oplossingen op het gebied van smaak, kwaliteit en service. De organisatie heeft een groepsstructuur met centraal beleid en lokale uitvoering. Daardoor werken locaties samen met het centrale QA-team en met andere sites. De fabriek in Zeewolde is volop in beweging, met nieuwe projecten, ambities en verbetertrajecten. Kwaliteit krijgt er vorm in de dagelijkse praktijk en is niet alleen een verantwoordelijkheid van één afdeling, maar ook een gedeelde verantwoordelijkheid binnen de organisatie. Het bedrijf hecht waarde aan een mensgerichte en resultaatgerichte cultuur, met samenwerking, respect en ambitie als kernwaarden. Binnen de lokale kwaliteitsfunctie werken QA en QC samen. De Quality Manager geeft leiding aan een QA Officer en een QC Lab-team en rapporteert aan de Site Manager. Daarbij is er nauwe samenwerking met de Group QA Manager binnen de divisie. Ook zijn er contacten met productie en de technische dienst. De organisatie combineert daarmee aandacht voor mensen en samenwerking met het werken aan kwaliteitsbeleid, audits en continue verbetering.
Wil jij in regio Zeewolde tot €4600 verdienen als QHSE Manager? Solliciteer dan direct!

Functie-inhoud:

• Als Quality Manager ben je verantwoordelijk voor de kwaliteit binnen de fabriek en voor de vertaling van het centrale QA-beleid naar de lokale praktijk
• Je geeft leiding aan en coacht het QA- en QC-team
• Als Quality Manager ontwikkel en implementeer je een toekomstbestendig kwaliteitssysteem
• Je coördineert interne en externe audits en bewaakt de naleving van IFS, SQMS, Kosher- en halalstandaarden en klantvereisten
• Je analyseert en verbetert QA- en QC-processen, procedures en werkinstructies
• Je werkt samen met andere QA Managers binnen de Group en verbindt QA, productie en technische dienst

Functie-eisen:

• Je hebt een afgeronde hbo- of wo-opleiding, bij voorkeur in Levensmiddelentechnologie, Voedingsmiddelentechnologie, Bedrijfskunde of een vergelijkbare richting
• Je hebt minimaal 3 jaar ervaring in een leidinggevende positie binnen kwaliteitszorg, bij voorkeur in de voedingsmiddelenindustrie
• Je hebt kennis van en ervaring met kwaliteitssystemen zoals IFS, BRC of FSSC22000 en relevante wet- en regelgeving
• Je bent een energieke persoonlijkheid die graag bouwt aan een organisatie en samen met een team resultaten behaalt
• Je communiceert sterk in het Nederlands en Engels en verbindt de werkvloer met het management

Wij bieden:

• Salaris: €2.800 – €4.600 bruto per maand
• 25 vakantiedagen, 11,5 ATV-dagen en 8% vakantiegeld
• Een eindejaarsuitkering van 5%
• Een bonus van 10% van je jaarsalaris, gebaseerd op persoonlijke doelstellingen en gezamenlijke doelen
• Een pensioenregeling
• Een Leadership for Growth-programma voor je professionele ontwikkeling
• Iedere donderdag een snack met ingrediënten van het bedrijf, zodat je de producten kunt proeven en testen
• De mogelijkheid om mee te doen aan de feestcommissie
• Reiskostenvergoeding
• Laptop en telefoon van de zaak
• Mogelijkheden om verschillende cursussen te volgen

Over de vacature

Are you an experienced laboratory technician looking for the next step in your career? Do you want to play a pivotal role in ensuring the quality and effectiveness of life saving discoveries worldwide? Salary starting at €3502 per month and 36 holidays per year. Interested? Apply now and join our QC team at Johnson & Johnson in Leiden as a Senior Lab Technician.

what we offer

• €3502 - €4300 gross, based on experience.
• Contract for a year, with chance of extension
• International and innovative work environment
• Dedicated internal learning and development
• Work at the Bio-Science Park in Leiden
• Full coverage for public transport

who are you
As a Senior Technician Microbiology you meet the following requirements:

• You speak English
• You are available for 40 hours per week
• You are willing to work in Leiden
• You have an MLO or HLO degree
• You have at least three years of relevant QC laboratory experience
• You have experience with GMP
• You have experience with deviation or non-conformance writing
• You have experience training employees or supporting troubleshooting

what will you do
As a Senior Lab Technician at the Microbiology department, you are responsible for performing microbiological analyzes. Various techniques are used for this, such as Environmental Monitoring, Bioburden, Endotoxin determination (LAL), sterility test and identification of micro-organisms. All tests are performed in accordance with Good Manufacturing Practices / Good Laboratory Practices.
Your role will include:

• Perform microbiological analyses including Environmental Monitoring, Bioburden, Endotoxin determination (LAL), sterility tests, and microorganism identification.
• Troubleshoot assay-related issues and act as a Single Point of Contact for your team and support inspections.
• Train other lab staff on advanced methods and ensure accurate data entry, reporting, and documentation.
• Contribute to process optimization and simplification.

where will you work
Johnson & Johnson Innovative Medicine is part of Johnson & Johnson. Johnson & Johnson Innovative Medicine has a leading position in the world of biotechnology. They develop, produce and sell medicines and vaccines that are used worldwide in the fight against cardiovascular, vascular and infectious diseases and autoimmune diseases such as Crohn's disease and Rheumatism.

• Enjoy 36 holidays per year.
• Public transport 100% reimbursed and/or 0,23 cent per km by car.
• Enrollment in Randstad pension plan.
• Free online/physical training via GoodHabitz and johnson & Johnson Learning & Development program.
• To apply for this job it is important that you have a European passport or a valid work permit for working in the Netherlands valid for at least 3 years

job application
Good to know: within 15 minutes of applying, you will receive a WhatsApp message from us. We will ask you a few short questions about your application so we can assist you faster. Don't have WhatsApp? No problem! In that case, we will contact you by phone or email.