Quality Assurance Specialist – Cell Therapy

Bring your Quality experience to Cell Therapy.

Join our growing Cell Therapy team in Amsterdam in a hands-on Quality role. You will work with batch documentation, Quality systems and QPs, while helping us improve our processes as our operations grow.

Quality Assurance Specialist – Cell Therapy

Amsterdam

Full-time or 4 days per week

Hybrid, 3 days on-site

The role

As a Quality Assurance Specialist, you combine hands-on Quality Assurance with Global Quality Management System (QMS) activities.

You work closely with our Qualified Persons (QPs) and Quality colleagues to make sure documentation is complete and correct, Quality actions are followed up and our operations remain compliant. You also help improve Quality processes and ways of working as our site develops.

Our Cell Therapy operation in Amsterdam is growing, and we are building our Cell Therapy Import Hub. To support this growth, we are expanding our Quality team.

What will you do?

Around 70% of your role is focused on daily Quality operations, including batch documentation review, quality records review, compiling the Batch disposition packet and working with our QPs. Around 10% is focused on improving processes and ways of working, with the remaining time spent on Global QMS activities, training, meetings and follow-up.

• Review batch documentation for batch disposition/QP certification.

• Identify missing or incomplete documentation, coordinate actions with the right teams and follow them through to completion.

• Write, review and update SOPs, procedures, policies and other Quality documents.

• Review Quality and manufacturing records and identify gaps, risks, deviations and required follow-up.

• Investigate Quality deviations and coordinate corrective and preventive actions (CAPAs).

• Review and approve Change Controls.

• Facilitate & Coordinate Change Control Review Board Meetings.

• Compile, evaluate and present Quality Systems data and metrics for Quality Management Review Meetings.

• Train colleagues on GMP, QMS procedures and other core Quality processes.

• Prepare for audits and inspections and participate in audit and inspection activities.

• Review Quality documentation for equipment and facility as we build our Cell Therapy Import Hub.

• Identify Quality or compliance concerns, take action and escalate when needed.

• Use available digital and AI tools to improve and update Quality documentation.

Who are you?

You enjoy detailed, documentation-driven work. You like reviewing documents, checking details and making sure Quality records are complete, correct and compliant.

You take ownership. When something needs attention, you follow it up, involve the right people and make sure it gets resolved.

You will work in a small Quality team on a site that is still developing. Processes and priorities can change as we build the organisation. You are comfortable with this, stay calm under pressure and look for practical solutions.

You are self-motivated, flexible and curious. You can manage several priorities at the same time and actively look for ways to improve how things are done.

Essential skills and experience

• A bachelor’s or master’s degree.

• At least 2 years of hands-on Quality Assurance experience in a GMP manufacturing environment.

• At least 2 years of experience writing and reviewing Quality documentation, including SOPs and procedures.

• At least 2 years of experience with deviations, CAPAs and change controls.

• Experience reviewing batch documentation and Quality records.

• Good knowledge of GMP and Quality Systems.

• Knowledge of and ability to apply GMP in conformance to US, EU and ROW standards.

• The ability to identify gaps and risks in Quality records and determine what follow-up is needed.

• Experience working with an electronic QMS. Veeva experience is an advantage.

• Professional proficiency in English; Dutch is a plus.

Desirable skills and experience

Experience in Cell Therapy is a strong advantage, especially because of the specific requirements around batch disposition and release. Experience in biologics is also highly relevant.

You must currently live within commuting distance of our Amsterdam site.

Why join us?

You will join our Amsterdam Cell Therapy operation at an important stage of growth. As we build our Cell Therapy Import Hub, you will work in a small Quality team where you can use your hands-on experience and contribute ideas to improve processes and ways of working.

This is a meaningful role with real impact on quality, compliance, and continuous improvement. You will join a collaborative and professional working environment where your expertise is valued. There is room for initiative, ownership and personal development.

The role offers a varied combination of daily Quality operations and Global QMS activities in a developing Cell Therapy environment. You will work closely with QPs and other colleagues, with room to take responsibility, solve problems and develop your Quality experience further.

Your effort is rewarded

As a Quality Assurance Specialist, you can expect much in return for your dedication. In addition to a competitive salary, you will enjoy:

• An attractive bonus scheme and a 13th-month salary on top of your monthly pay.

• Career growth opportunities, including international prospects.

• Access to internal training and development programs.

• 27 vacation days, plus additional leave (such as your birthday, Good Friday, and the period between Christmas and New Year's Eve).

• Flexible and progressive employment benefits, allowing you to tailor them to your needs (e.g., a wellness budget and the choice of a holiday calendar based on different religious beliefs).

• A pension plan.

• Opportunity to participate in our share purchase plan with an additional contribution from AstraZeneca.

Making a difference together with AstraZeneca

Are you driven by innovation in cancer treatment and eager to make a real impact? At AstraZeneca's R&D Cell Therapy facility in Amsterdam, we are developing next-generation TCR therapies targeting neoantigens in solid tumours. With a team of approximately 75 scientists, we are advancing both fully individualised and shared neoantigen-targeting treatments to transform patient outcomes.

This state-of-the-art space is designed to accelerate breakthroughs in cell therapy. Join our team and help shape the future of cancer treatment.

Ready to grow your career in one of AstraZeneca's Cell Therapy teams? Apply now!

How to apply

If you have any questions about this vacancy, please contact our Recruitment Team, Karin Raadschelders or Caroline van Oppen, via info@werkenbijastrazeneca.nl or +31 (0)85 047 0244.

We don't work with a fixed closing date; we will commence our screening process immediately; the vacancy will close as soon as we've found the right candidate.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.