Quality Assurance Associate – Delegate Qualified Person

Biopharma Asia; Antwerpen; Hybrid; EUR 60,000 - 85,000; Full time

Job summary

Johnson & Johnson in Belgium is seeking a Quality Assurance Associate – Delegate Qualified Person to join the R&DQA-Clinical Supply Quality team. You will collaborate with global quality partners to ensure timely release and QP certification for clinical materials.

You will learn across products, technologies, and regulatory expectations while growing in a fast-paced, cross-cultural setting with broad responsibilities as your experience develops.

Qualifications

• Required: a university industrial pharmacist degree and qualification as EU‑certified Qualified Person residing in Belgium.
• Experience in pharmaceutical supply chain or quality assurance is advantageous.
• Willingness to learn, take responsibility and apply quality requirements to decisions.
• Exposure to product release or production is an advantage; prior release experience not essential.

Responsibilities

• Connect with Clinical Supply Chain teams and global quality partners to gather and follow information for timely release and QP certification.
• Support quality from the start by contributing to cross-functional teams and incorporating quality requirements into trial execution.
• Assist in releasing clinical trial materials by reviewing batch information and performing release activities within the Janssen R&D IMP license.
• Apply GMP and GDP guidelines and assist teams in following established guidance and seeking expert input when needed.
• Assist in investigations of deviations and complaints, support CAPAs, and elevate risks to quality colleagues.
• Contribute to quality systems and maintain documentation; help implement sustainable process improvements.
• Support audit and inspection readiness, preparing documentation and assisting during customer audits and Health Authority inspections.

Skills

QA processes

GMP/GDP

QA documentation

Cross-functional work

Education

Industrial Pharmacist degree

EU-certified Qualified Person

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium

Job Description:

Quality Assurance Associate – Delegate Qualified Person

Do you want to develop your quality expertise while helping innovative medicines reach clinical trial patients around the world? Are you a recognized Qualified Person residing in Belgium and looking to build your experience? Join our team as a Quality Assurance Associate- Delegate Qualified Person in R&DQA- Clinical Supply Quality. You will work with experienced colleagues across global clinical supply chains for synthetics, biotherapeutic molecules and advanced therapy medicinal products (ATMPs). From reviewing clinical batch documentation to supporting quality investigations and process improvements, your work will help enable safe, compliant and timely delivery to clinical trials.

You will build your QA and Delegate QP experience with support from experienced colleagues, taking on broader responsibilities in line with your training and authorization.

You will broaden your knowledge of products, technologies and regulations while collaborating with colleagues worldwide. 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, supporting medicines as they progress towards commercialization. You will gain experience in a dynamic, fast-paced environment where adaptability and practical thinking are valued.

Learning and development: gain hands‑on exposure to different products, technologies, supply chains and worldwide regulatory expectations.

Growing responsibility: develop your quality judgement, contribute to investigations and put improvements into practice with guidance from experienced colleagues.

Global collaboration: work with multidisciplinary teams and external partners across Europe and the US.

Exposure and growth: build your quality expertise, learn from colleagues and support preparation for audits and Health Authority inspections. Develop an understanding of the end-to-end product supply chain.

Contribute fresh ideas: ask questions, identify opportunities to improve existing processes and help turn ideas into practical solutions.

Learn in an innovative environment: explore how quality processes evolve to support new technologies and contribute to their development alongside experienced team members.

What you will do

Connect with the right experts: work with Clinical Supply Chain teams and global quality partners, including J&J (pilot) plants, ECSQ, Quality Asset Management to gather and follow up the information needed for timely release and QP certification.

Support quality from the start: contribute to cross-functional teams alongside experienced Clinical Supply Quality colleagues and help incorporate quality requirements into clinical trial execution.

Support release of clinical trial materials: review batch information and perform assigned release activities within the Janssen R&D IMP license, following appropriate training and authorization. Build towards broader Delegate QP responsibilities as your experience develops, helping to keep clinical studies supplied.

Apply quality requirements in practice: develop your understanding of GMP, GDP and clinical‑trial requirements and help operational teams apply established guidance, seeking expert input when needed.

Help resolve quality issues: support timely investigations of deviations and complaints, contribute to defining and following up CAPAs, and promptly elevate potential patient or supply risks to the appropriate quality colleagues.

Contribute to quality systems: support selected quality‑system activities, maintain accurate documentation and help implement sustainable process improvements.

Support audit and inspection readiness: help prepare documentation and provide support during customer audits and Health Authority inspections, working alongside experienced QA colleagues.

What you bring

Required: a university industrial pharmacist degree and qualification as EU‑certified Qualified Person residing in Belgium.

Initial experience in pharmaceutical supply chain, quality assurance or a closely related environment is an advantage. Candidates at the start of their career who meet the required QP qualification are welcome to apply.

A willingness to learn, take responsibility for assigned activities and develop your ability to apply quality requirements to practical decisions.

Exposure to product release, operational quality or production is an advantage; prior product‑release experience is not essential.

How you will thrive

You have a foundational understanding of pharmaceutical production and quality systems and are keen to deepen it; exposure to sterile manufacturing is an advantage.

You are familiar with cGMP principles and willing to develop your knowledge of ICH guidelines and internal standards, applying them with guidance where needed.

You communicate clearly, ask questions when something is unclear and build constructive working relationships across cultures and time zones.

You organize assigned work carefully, follow through on commitments and seek support when priorities compete or issues fall outside your experience.

You are keen to understand how your quality activities contribute to the wider clinical supply chain and reliable patient supply.

You are curious about new technologies, open to feedback and different perspectives, and willing to learn as circumstances change.

You approach problems methodically, gather relevant information and contribute to risk assessments and practical action plans with guidance from experienced colleagues.

#SCQuality

Required Skills:

Preferred Skills: