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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? Apply today.

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 escalate 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 experience.

How you will thrive

• You understand pharmaceutical production and quality systems; knowledge of sterile manufacturing is an advantage.

• You can work with cGMP, ICH guidelines and internal standards, and translate them into clear, risk-based actions.

• You communicate confidently, build productive stakeholder relationships and collaborate effectively across cultures and time zones.

• You are comfortable working independently, setting priorities and taking ownership in a complex, changing environment.

• You connect quality decisions to the bigger business and patient-supply picture.

• You are curious about new technologies, open to different perspectives and ready to adapt when circumstances change.

• You approach problems creatively, assess risks thoughtfully and turn conclusions into clear action plans.

#SCQuality

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The anticipated base pay range for this position is:

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.