Delegate Qualified Person Clinical Supply Quality

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

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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? 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

 

 

Required Skills:

 

 

Preferred Skills:

Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)

  

 

The anticipated base pay range for this position is:

€72 500,00 - €115 230,00

 

 

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.