As a Qualified Person at AstraZeneca, you certify cell therapy products for patients across Europe. You help establish a new import hub in Amsterdam, taking on legal responsibility from day one within one of the fastest-growing areas of our business.
Qualified Person (QP) – Cell Therapy
Amsterdam
Full-time, hybrid (3 days on-site)
Introduction
As a Qualified Person (QP) at AstraZeneca, you certify ATMPs for EU and UK clinical trials and ensure GMP compliance, product quality and patient safety.
This is a rare opportunity to help establish a new import hub in Amsterdam within AstraZeneca's rapidly expanding Cell Therapy business.
You will work alongside experienced international colleagues while taking on real responsibility in an organisation investing heavily in the future of cell therapy.
You will report to the Site Quality Lead in Amsterdam and work closely with AstraZeneca’s international Cell Therapy Quality organisation.
Our cell therapy products are manufactured in the US, imported through the Netherlands, and certified for use across Europe. Each product is made for an individual patient and has a very short shelf life, making quality, precision and timely decision-making essential.
In this role you will:
Certify ATMP Investigational Medicinal Products (IMPs) for EU and UK clinical trials.
Act as a named QP, taking legal responsibility for GMP compliance, product quality and patient safety.
Lead and support audits and inspections.
Perform internal & external audits utilizing a risk-based strategy and ensuring quality systems enable operations/manufacturing and analytical activities.
Provide EU GMP expertise to manufacturing sites in the US and contribute to the development of cross-site quality systems, procedures and standards.
Drive continuous improvement initiatives and contribute to quality risk management across the Cell Therapy network.
Build and maintain strong working relationships with Quality, Manufacturing and Supply Chain colleagues across Europe and the United States.
Assess deviations and out-of-specification results, making scientifically sound decisions that balance patient safety, product quality, regulatory compliance and supply.
Provide Quality oversight for the Amsterdam site and support the local Quality team where needed.
Who are you?
You are someone who takes ownership and is comfortable making well-founded scientific decisions within a highly regulated environment. You communicate clearly and build strong relationships across international teams. You work with a high level of integrity, have a strong quality mindset and understand the responsibility that comes with certifying patient-specific products.
Essential skills/experience:
You hold a master’s degree in Pharmacy, Biology, Biotechnology, Engineering or another relevant life sciences discipline.
At least 8 years of pharmaceutical industry experience, including a minimum of 2 years as a registered Qualified Person.
Experience supporting regulatory inspections and performing internal and external audits.
Experience with cell therapy, biologics or ATMP manufacturing and batch disposition is essential.
Proven track record of working in a fast-paced, cross-functional work environment.
Strong knowledge of GMP requirements and their practical application across EU, US and global manufacturing environments.
You hold a valid EU passport or have unrestricted permission to work in the European Union, and you are already living in the EU, as batch certification must take place within the European Union.
Fluent in English. Proficiency in Dutch, both written and spoken, is a plus.
You are self-motivated, detail-oriented, have excellent interpersonal, and willing to accept temporary responsibilities outside of job description.
Desirable Skills/Experience:
Experience in the disposition of sterile products for clinical and/or commercial use (biologicals and/or ATMPs).
Experience writing, evaluating and closing investigations, CAPAs and Change Control records.
Experience with Cell Therapy regulatory inspections.
Why join us?
AstraZeneca is making significant investments in its Cell Therapy organisation, giving you the opportunity to help shape new quality processes and ways of working within a rapidly growing global network.
You will be part of a highly specialised QP community, with opportunities to collaborate internationally and contribute to the further development of Cell Therapy within AstraZeneca.
Your effort is rewarded
As a Qualified Person, 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? !
How to apply
If you have any questions about this vacancy, please contact our Recruitment Team, Karin Raadschelders or Caroline van Oppen, via [email protected] 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
15-jul.-2026
Closing Date
14-okt.-2026
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.
