Delegate Qualified Person Clinical Supply Quality

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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium

Job Description:

Do you want your quality decisions to help innovative medicines reach clinical trial patients around the world? Are you a recognized Qualified person residing in Belgium? Join our team as a Delegate Qualified Person in R&DQA- Clinical Supply Quality. You will work at the heart of global clinical supply chains for synthetics, biotherapeutic molecules and advanced therapy medicinal products (ATMPs).

Every day is different: from reviewing a clinical batch to resolving an unexpected quality issue and building a new quality framework, your work will directly support safe, compliant and timely delivery to clinical trials.

This is a role for someone who wants more than a checklist. You will build broad expertise across products, technologies and regulations, collaborate with colleagues worldwide, and become a trusted quality partner whose judgement makes a visible difference.

Ready to bring quality closer to patients?

What you can expect from this role

• Meaningful impact: help clinical trial materials reach patients safely and on time. Advancing medicines into commercialization.
• You will operate in a dynamic, fast-paced environment where agility and out-of-the-box thinking are valued
• A steep learning curve: gain hands-on exposure to different products, technologies, supply chains, worldwide regulatory expectations and different leadership levels. Real ownership: make and defend quality decisions, lead investigations and see your improvements put into practice.
• Global collaboration: work with multidisciplinary teams and external partners across Europe and the US.
• Visibility and growth: develop as a quality expert, coach colleagues and represent QA during audits and Health Authority inspections. Connect the dots end to end across the product.
• Challenge status quo: challenge existing processes and turn good ideas into sustainable solutions.
• Work outside existing frameworks: you are at the heart of innovation, current processes might not always meet the needs of the innovation, you will be required to shape processes.

What you will do

• Bring the right experts together: work closely with Clinical Supply Chain teams and global quality partners to secure the input needed for timely release and QP certification.
• Influence quality from the start: represent Clinical Supply Quality in cross-functional teams and ensure quality requirements are built into clinical trial execution.
• Release clinical trial materials: review batch information and perform release activities within the Janssen R&D IMP license, helping to keep clinical studies supplied.
• Turn regulations into practical guidance: advise and coach operational teams on GMP, GDP and clinical-trial requirements.
• Solve real quality issues: guide timely investigations of deviations and complaints, help define effective CAPAs and elevate potential patient or supply risks appropriately.
• Improve the system: own selected quality-system processes, challenge the status quo and implement sustainable improvements.
• Represent your expertise: act as a QA spokesperson during customer audits and Health Authority inspections.

What you bring

• Required: a university industrial pharmacist degree and qualification as EU-certified Qualified Person residing in Belgium.
• At least three years of experience in pharmaceutical supply chain, quality assurance or a closely related environment.
• An interest in taking ownership, learning quickly and applying quality requirements to practical decisions.
• Experience with product release is an advantage, but we also value relevant operational quality or production exp