Bring your audit & Quality experience to Cell Therapy

Join our growing Cell Therapy team in Amsterdam on a 12-month contract, in a hands-on role centred on hosting audits and Health authority inspections. You will work with batch records, Quality systems and QP’s, while helping us improve our processes as our operations grow.

Quality Assurance Specialist – Cell Therapy

Amsterdam

12 month contract

Hybrid, 3 days on-site

The role

As a Quality Assurance Specialist, you combine hands-on Quality Assurance with audit and inspection activities and broader Quality Management System (QMS) responsibilities.

In this role, you’ll play a key part in ensuring quality and compliance across our operations. Around 50% of your time will be dedicated to compiling and reviewing batch documentation, 30% on broader QMS activities, and 20% to supporting audits and self-inspections. You work closely with our Qualified Persons (QP’s) and Quality colleagues to make sure documentation is complete and correct, Quality actions are followed up and our operations remain compliant. You also help to improve Quality processes and ways of working as our site develops.

What will you do?

A key part of your role will be supporting day-to-day Quality operations, with a strong focus on batch documentation compilation and review. You’ll also contribute to QMS activities, training and meetings, as well as audits, inspections and the follow-up actions that arise from them.

Daily operation task include:

• 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 SOP’s, procedures, policies and 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 (CAPA’s).
• Review and approve Change Controls.
• Review Quality documentation for equipment and facility as we build our Cell Therapy Import Hub.
• Use available digital and AI tools to improve and update Quality documentation.

• Host audits forHealth authority inspections on site, including preparation, front room and backroom support, and follow-up.
• Coordinate audit and inspection activities
• Compile, coordinate and draft responses to audit and inspections findings, working with the business to make sure responsesare complete and consistent.
• Own the CAPA’s arising from audits and inspections, coordinate them with the responsible teams and follow them through to completion.
• Conduct self-inspections on site and drive the actions that come out of this to closure.

Who are you?

You are experienced in audits and inspections. You know what auditors and inspectors look for and stay calm and organised when they are on site.

You enjoy detailed documentation-driven work. You like reviewing documents, checking details and making sure Quality records and Batch documentation 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. Including the CAPA’s that follow an audit.

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.
• Experience hosting audits and Health authority inspections.
• Experience coordinating audits and inspections, compiling responses to findings, and managing the resulting CAPA’s.
• Experience conducting self-inspection.
• 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 and of broader QMS management.
• 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.

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:

• A 13th-month salary on top of your monthly pay.
• 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.
• This is a 12 month temporary contract position. Payroll and salary administration for this role are handled by an external agency.

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 [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

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.