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)

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.

• 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.

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.

• 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.

• 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.
• Opportu…