Quality regulatory affairs specialist economic operator ivdrmdr Vacatures

Over de vacature

As a Senior Quality Assurance Associate – Clinical Supply Chain , you will be responsible for ensuring that medicines used in clinical trials meet the required quality and regulatory standards.
You will oversee quality processes related to the packaging, labelling, storage and distribution of clinical trial products. You will also work closely with departments such as Production, Warehouse, Supply Chain, Quality and Regulatory Affairs to ensure compliance throughout the entire process.
Your main responsibilities will include:

• Reviewing batch documentation to support the certification and release of investigational medicinal products in accordance with EU and international regulations.
• Reviewing and approving clinical trial label artwork to ensure compliance with regulatory requirements.
• Assessing temperature deviations during transportation and storage at clinical sites.
• Investigating and resolving quality and compliance issues related to the manufacturing and distribution of clinical products.
• Reviewing and approving minor deviations, ensuring that all procedures and regulatory requirements are followed.
• Creating, updating and reviewing Standard Operating Procedures (SOPs) and Work Instructions.
• Preparing monthly quality reports and monitoring key performance indicators.
• Collaborating with different departments to identify quality risks and implement improvements.
• Providing hands-on Quality Assurance support during clinical packaging and labelling activities, including packaging checks, batch record reviews and resolving quality-related issues.
• Performing QA compliance checks to ensure that GMP and GDP standards are consistently maintained.

Please note that we are unable to consider candidates who require visa sponsorship or who live too far from the work location. Candidates who would need to relocate can only be considered if they have already secured accommodation within a reasonable commuting distance.

Requirements

• A Master's degree in Life Sciences, Pharmaceutical Sciences, Biotechnology or a related scientific field.
• Approximately 3 years of relevant experience in Quality Assurance or manufacturing within the pharmaceutical or medical device industry.
• Experience with batch record reviews, quality investigations and/or analytical testing.
• Good knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/or Good Clinical Practice (GCP).
• Excellent English communication skills, both written and spoken (C1 level).
• Strong attention to detail and a quality-focused mindset.
• Good analytical and problem-solving skills.
• The ability to communicate effectively and collaborate with different departments.
• A proactive attitude, willingness to learn and ability to take ownership of responsibilities.
• Currently residing in the Netherlands or within a reasonable commuting distance of Breda.

Benefits

• This is a 1-year contract position through Undutchables
• Working hours: Full-time (40 hours/week)
• Competitive salary package.
• Pension scheme
• Travel expense reimbursement, dependent on distance.
• Dynamic, international, and collaborative work environment with excellent development opportunities.

Application Procedure

If you are interested in this vacancy, you can apply by clicking on the button above. By clicking on apply, you agree to our privacy commitment and terms and conditions . Your application will be sent directly to the recruiter in charge. IMPORTANT: if you are not yet registered with Undutchables we kindly ask you to do so. Your information will be handled in the strictest confidence and your CV will not be sent to a company unless you have given prior permission. Curious about how the recruitment process works within Undutchables, click here to read more.

Over de vacature

Please note before applying: We can only consider candidates who are already settled in the Netherlands. This position does not offer sponsorship. Applicants must have a valid work permit for the Netherlands.
As a Supply Chain Project Manager, you will play a key role in the successful launch and lifecycle management of pharmaceutical products. You will coordinate supply chain activities across different departments, ensure projects stay on track, and make sure product launches and changes are implemented on time and in line with quality requirements.You will translate product launch and lifecycle strategies into clear supply chain plans and coordinate their execution from start to finish. A major part of the role is managing change controls, tracking project milestones, and bringing together stakeholders from different functions to ensure smooth implementation.
Key Responsibilities

• Lead and coordinate end-to-end supply chain projects related to new product launches, product changes, and lifecycle management.
• Own and maintain the overall project plan , ensuring activities, deadlines, and milestones are clearly defined and followed.
• Manage Change Controls and make sure they are implemented correctly, on time, and in line with company procedures.
• Organize and facilitate Product Lifecycle Team and Project Management meetings.
• Coordinate closely with departments such as Quality Assurance, Regulatory Affairs, Production, Planning, Artwork, Warehouse, Customer Service, and Procurement.
• Support the implementation of new products, product variations, packaging changes, and other lifecycle activities.
• Prepare project updates, reports, and key performance metrics for internal stakeholders and management.
• Support the development of project plans, project charters, workshops, and business cases.
• Identify potential issues and opportunities for improvement and lead projects to make processes more efficient.
• Act as a central point of contact to ensure all relevant stakeholders are aligned and that projects progress smoothly.

Requirements

• Bachelor’s degree or equivalent with typically 3–5+ years of relevant professional experience , or
• Master’s degree or equivalent with typically 1–3+ years of relevant professional experience , or
• PhD or equivalent with relevant professional experience.
• Previous experience in Project Management , ideally in a complex, cross-functional environment.
• Strong analytical and problem-solving skills with the ability to identify issues and develop practical solutions.
• Excellent communication and stakeholder management skills .
• Strong organizational skills and the ability to manage multiple projects, priorities, and deadlines simultaneously.
• A proactive and collaborative approach to working with different departments and stakeholders.
• Experience in the pharmaceutical industry is preferred.
• Knowledge of Supply Chain, product launches, change management, or lifecycle management is an advantage.

Benefits

• Full-time position.
• Competitive salary package.
• 30 Holidays.
• Travel reimbursement, dependent on distance.
• Hybrid position plus working from home allowance.
• 1 year Contract via Undutchables with long-term growth opportunities in a dynamic, international setting.

Application Procedure

If you are interested in this vacancy, you can apply by clicking on the button above. By clicking on apply, you agree to our privacy commitment and terms and conditions . Your application will be sent directly to the recruiter in charge. IMPORTANT: if you are not yet registered with Undutchables we kindly ask you to do so. Your information will be handled in the strictest confidence and your CV will not be sent to a company unless you have given prior permission. Curious about how the recruitment process works within Undutchables, click here to read more.

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.