Qa compliance specialist Vacatures

Over de vacature

QA Compliance SpecialistGeleen, Netherlands

The actual location of this job is in Geleen. Relocation assistance is available for eligible candidates and their families, if needed.

As a QA Compliance Specialist, you will help strengthen the site's Quality Management System (QMS) and support compliance with GMP, regulatory requirements, and Lonza Global Quality Standards. Working across functions, you will contribute to inspection readiness, quality systems, supplier management, and continuous improvement activities that support the delivery of high-quality medicines and services.

This is a fully site-based role. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Opportunities to develop your expertise across quality systems, compliance, supplier management, and GMP activities.
• A collaborative environment where you can contribute to continuous improvement and make a meaningful impact.

The full list of our global benefits can be found here:

The full-time annual base pay for this position in is expected to range between EUR 41,250 and EUR 57,750. 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:

• Support the site's Quality Management System, including quality documentation, training administration, quality records, and related quality systems activities.
• Contribute to the review and management of deviations, CAPAs, change controls, risk assessments, and other quality system processes, helping maintain an effective and compliant QMS.
• Coordinate supplier and service provider qualification activities, supplier complaints, and vendor change notifications in collaboration with site and global stakeholders.
• Support material setup and supplier lifecycle management activities as part of the site's wider quality and compliance framework.
• Support internal, customer, and external audits and regulatory inspections, helping maintain inspection readiness across the site.
• Deliver or support GMP and compliance-related training and awareness activities, working with colleagues across functions to strengthen quality culture.
• Identify opportunities to improve quality systems and compliance processes, contributing to continuous improvement initiatives and the ongoing effectiveness of the Quality organization.

What we are looking for:

• A bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Chemistry, or a related discipline, or equivalent relevant experience.
• Experience working in a GMP-regulated pharmaceutical, biotechnology, medical device, or similar quality environment is advantageous.
• Working knowledge of GMP principles, Quality Management Systems, and quality compliance requirements.
• Strong organizational and documentation skills, with attention to detail and the ability to manage multiple priorities and deadlines.
• Effective communication and collaboration skills, with the ability to work confidently with colleagues and stakeholders across different functions.
• A proactive, problem-solving mindset and genuine interest in quality systems, supplier management, compliance, and continuous improvement.
• Proficiency with Microsoft Office; experience with SAP, document management systems, or learning management systems would be an advantage.

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

Senior QA Compliance SpecialistGeleen, Netherlands

As a Senior QA Compliance Specialist, you will play a key role in maintaining and strengthening the Quality Management System (QMS) at our Geleen site. As a subject matter expert in QMS and quality event processes, you will help ensure GMP compliance, support inspection readiness, and drive continuous improvement across the site.

What you will get:

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Opportunities to work cross-functionally and contribute to continuous improvement within a global life sciences organization.
• A variety of benefits dependent on role and location.

The full list of our global benefits can be found here:

The full-time annual base pay for this position in the Netherlands is expected to range between EUR 46,500 and EUR 65,100. 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:

• Provide oversight of the site's Quality Management System, including quality events, quality risk management activities, and compliance programs.
• Lead the Deviation Review Board and review and approve systemic quality events, including deviations, CAPAs, change requests, investigations, and audit commitments.
• Author, review, and maintain QMS documentation and support implementation of site and global quality standards.
• Review and approve quality risk assessments and support the implementation of risk management activities.
• Support internal and external audits, regulatory inspections, and ongoing inspection readiness activities.
• Deliver training on QMS and compliance topics, helping strengthen GMP knowledge and a culture of quality across the site.
• Identify and implement improvements to quality systems and compliance processes while working closely with cross-functional stakeholders.

What we are looking for:

• At least 5 years of experience in quality management, quality systems, or compliance within a GMP-regulated pharmaceutical or biotechnology environment.
• Strong experience managing quality events, including deviations, CAPAs, change requests, investigations, and quality risk management activities.
• Solid knowledge of QMS principles, GMP requirements, risk management, and inspection readiness.
• Experience supporting audits, regulatory inspections, and broader compliance programs; experience in sterile manufacturing is an advantage.
• Strong analytical, problem-solving, decision-making, and stakeholder management skills, with the ability to work effectively across functions.
• Experience developing or delivering training on quality and compliance topics.
• A bachelor's degree or equivalent qualification in a relevant discipline, ideally supported by experience in a life sciences 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

The actual location of this job is in.

Join our Quality Assurance team and play a key role in ensuring that life-changing medicines are manufactured to the highest quality and compliance standards. As a QA Specialist / Officer II, you will work closely with manufacturing and cross-functional teams to support GMP operations, review quality documentation, and help drive continuous improvement across our production processes.

This is a fully site-based role. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get

• An agile career with opportunities for growth and development within a global life sciences company.
• An inclusive, collaborative and ethical workplace where your ideas are valued.
• Competitive compensation programs that recognize high performance.
• A comprehensive benefits package tailored to your role and location.
• Opportunities to work with cutting-edge biotechnology manufacturing technologies.
• The full list of our global benefits can be found here:

The full-time annual base pay for this position in the Netherlands is expected to range between EUR 41,250 and EUR 57,750. 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

• Partner with manufacturing and internal stakeholders as the Quality Assurance subject matter expert, providing guidance on GMP and quality-related activities.
• Review batch records and prepare documentation for batch disposition, ensuring completion within agreed timelines.
• Review and approve quality events including deviations, investigations, CAPAs and change controls while ensuring compliance with GMP requirements.
• Review and approve quality documentation including SOPs, master batch records, protocols, reports, forms and related documentation within the document management system.
• Support QA on the Floor activities by providing quality oversight during manufacturing, warehouse and quality control operations.
• Contribute to quality metrics, KPI reporting and cross-functional quality meetings to support continuous improvement initiatives.
• Ensure batch documentation is completed, archived and product labels are issued or verified in accordance with established procedures.

What we are looking for

• Bachelor's or Master's degree in Biotechnology, Life Sciences, Chemistry or another relevant scientific discipline.
• Experience working in a GMP-regulated manufacturing environment, ideally within biotechnology or pharmaceutical manufacturing.
• Experience in Quality Assurance or a related quality function with knowledge of GMP regulations and compliance requirements.
• Strong attention to detail with the ability to review technical documentation accurately and identify compliance risks.
• Excellent communication and collaboration skills, with the ability to build effective relationships across cross-functional teams.
• Ability to prioritize multiple activities, solve problems effectively and escalate issues appropriately when required.
• Business-fluent English, both written and spoken.

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

Sr.QA Validation Specialist

The actual location of this job is in Geleen, Netherlands. Relocation assistance is available for eligible candidates and their families, if needed.

Join Lonza as a Sr. QA Validation Specialist and play a key role in ensuring our facilities, utilities and equipment meet the highest quality and compliance standards. Working within Quality Assurance, you will provide expert oversight of validation activities and collaborate closely with Engineering, Manufacturing and other teams to support the safe, reliable and compliant production of medicines.

This is a fully site-based role. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

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.
• Opportunities to contribute to continuous improvement and international standardization.
• The opportunity to work at the interface of Quality Assurance, Engineering and Manufacturing within a global life sciences organization.

The full list of our global benefits can be found here: Lonza global benefits

The full-time annual base pay for this position in the Netherlands is expected to range between EUR 54,000 and EUR 75,600. 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:

• Oversee qualification and validation activities for equipment, facilities and utilities, ensuring deliverables meet applicable quality and regulatory requirements.
• Review and approve validation documentation, including user requirements, validation plans, design and qualification documents, commissioning documentation, and factory and site acceptance testing.
• Ensure traceability of requirements throughout the validation lifecycle, from user requirements through to performance qualification.
• Assess validation impact and support periodic reviews of validated equipment, facilities and utilities, including changes and improvements.
• Manage validation deviations and changes, ensuring appropriate documentation, corrective actions and follow-up are completed effectively.
• Provide quality and compliance support to Engineering, Manufacturing and Technical Services teams, applying current Good Manufacturing Practice (cGMP) and validation principles.
• Contribute to continuous improvement and standardization of validation processes and practices across the organization.

What we are looking for:

• 5-10 years of relevant experience in validation, quality assurance, quality control, control systems or a related area within a regulated manufacturing environment.
• A technical diploma, bachelor's or master's degree in Engineering, Biology, Biomedical Science, Life Science or a related discipline.
• Strong practical knowledge of validation methodologies, including qualification activities such as DQ, IQ, OQ and PQ.
• Experience working with cGMP, GxP, GAMP and relevant quality systems, with an understanding of European and FDA regulatory expectations.
• Strong analytical and problem-solving skills, with the ability to break down complex technical issues into clear, practical actions.
• Excellent written and verbal communication skills, with the ability to collaborate effectively across Quality Assurance, Engineering and Manufacturing.
• Strong organizational and time-management skills, with the ability to manage multiple assignments while maintaining high quality standards.

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.