Associate Director Qualified Person

In this senior QP role, you will guide some of the most intricate quality matters in biologics intended for early-phase clinical studies. You will operate with a high degree of independence, supported by a trusted global QP network that values open knowledge-sharing and thoughtful, well-grounded decision making.

This position offers clear, steady responsibilities and places your expertise at the heart of global batch release and quality discussions.

Associate Director Qualified Person (QP)
Nijmegen
Full-time (3 days in the office, 2 days hybrid)

Introduction
As an Associate Director Qualified Person (QP) at AstraZeneca, you play a key role in certifying batches for EU clinical trials and ensuring the quality of biologics used in early development. You collaborate closely with QPs and quality colleagues across Europe, the UK and the US and work within a well-established global QP network.
This position is available due to an upcoming retirement. During your first months, you will work side by side with the current EU QP and gradually take over responsibilities over the course of the next year.

You will report to the Director Development Quality Biologics who is based in Gaithersburg in the US. You will partner closely with AstraZeneca development and clinical groups to ensure efficient, compliant supply of IMPs, including comparators and non IMPs, to clinical trials.

What will you do?
In this senior QP role, you certify Investigational Medicinal Products (IMPs) for EU clinical trials and ensure compliance with EU GMP requirements for biologics manufacturing and supply.

You:
•    Certify IMP batches for EU clinical studies and maintain Product Specification Files.
•    Provide EU perspective and input to cross site quality systems and procedures, including EU compliance advice to the Gaithersburg pilot plant and development groups; apply standards and regulations using a risk based, phase appropriate approach.
•    Collaborate with the Nijmegen manufacturing license holder and QA/ QP colleagues in the EU, UK and US.
•    Support GMP and GCP inspections and act as subject matter expert during regulatory interactions.
•    May lead and participate in internal, external and CMO audits across or once in a while outside  Europe.
•    Support the management of quality events, including major events involving supply chain issues.

•    Contribute to global clinical supply process design and improvement projects.
•    Coach colleagues within the QP network and support due diligence and joint-venture activities.

Your work combines hands-on release responsibilities with cross-functional collaboration and participation in global improvement initiatives.

Hybrid model: Typically, 3 days on-site per week at the Nijmegen facility and 2 days remote, aligned with team and business needs.

Flexibility: Additional on-site days may be needed to support regulatory inspections, supplier audits, or critical supply chain events. Remote days should maintain core hours overlap with UK/EU time zones.

Who are you?
You are an experienced pharmaceutical professional with a strong background in GMP, biologics and clinical supply. You bring sound quality judgement, clear communication and a practical approach to resolving issues.
You remain clear-headed in high-stake situations, can explain your decisions clearly and enjoy working with international colleagues. You bring a senior level of experience, regardless of your background, and you value working with colleagues who respect different perspectives.

You also bring:
•    Bachelor’s degree or above in Pharmacy, Chemistry, Biology or a related discipline.
•    Eligibility under EU QP Directive 2001/83/EC.
•    14+ years of industry experience, including 5+ years as a QP for IMPs.
•    Extensive knowledge of biologics, EU GMP and EU clinical supply requirements.
•    Experience with audits and quality systems (Veeva or similar is a plus).
•    Ability to collaborate constructively, guide colleagues and offer constructive input when discussions require it.
•    Willingness to travel to EU CMOs (monthly/quarterly) and to the US (at the most once per year).
•    Interest in innovation and in finding improved ways of working.

What do we offer?
•    A senior QP role with responsibilities directly connected to early-stage clinical research.
•    A supportive, international QP network where experience is shared openly.
•    Flexibility and a culture built on clear communication and teamwork.
•    Opportunities to grow through complex release work, project leadership and global initiatives.
•    Excellent employment benefits, including:

o    27 vacation days + option to buy 10 extra days
o    1 paid volunteer day
o    €230 annual sports allowance
o    8% holiday pay
o    12.5% target bonus

The Clinical Supply Quality team
This team is responsible for quality oversight in the development of new clinical trials and collaborations, and for the supply of Investigational Medicinal Products (IMPs) to those trials.
Our portfolio spans small and large molecules, combination products, and groundbreaking technologies, enabling delivery of novel, life-changing medicines to patients around the globe. We collaborate across three countries as part of Development Quality, Biologics, covering all quality activities required for the development of new medicines.

About AstraZeneca
AstraZeneca works to improve quality of life for patients with serious diseases. We develop medicines in oncology, cardiovascular, renal and metabolic diseases, respiratory and immune disorders, and vaccines.
Globally, 75,000 colleagues work across six continents. In Nijmegen, around 100 colleagues produce, test, and package biologics for early clinical development. Our site plays a crucial role in bringing new medicines into first-in-human and early-phase studies.
We follow the science, put patients first, and strive to do the right thing. We value curiosity, collaboration, and continuous improvement - creating an environment where people can grow and thrive.

Apply
If you are interested and would like to apply, we look forward to receiving your CV.
Please use the apply button at the bottom of this vacancy.

Questions? Our Recruitment Team, Karin Raadschelders or Caroline van Oppen, is available at info@werkenbijastrazeneca.nl or +31 (0)85 - 047 0244.

We don’t work with a fixed closing date; the vacancy will close as soon as we’ve found the right candidates. Feel free to apply right away - we start the selection process immediately.

Date Posted

25-nov.-2025

Closing Date

23-mrt.-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.