Quality Assurance Associate – Delegate Qualified Person

Johnson & Johnson Co.; Geel; On-site; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Job summary

Johnson & Johnson in Belgium seeks a Quality Assurance Associate – Delegate Qualified Person to support release of clinical trial materials and ensure GMP/GDP compliance across global clinical supply chains. You will gain experience in QA, regulatory inspections, and QP responsibilities in a dynamic environment.

Proven ability to work with cross-functional teams, coupled with a university-level QA/Pharma background and EU QP status in Belgium, will help you contribute to timely, compliant

Qualifications

• Requires EU-certified Qualified Person residing in Belgium.
• Experience in pharmaceutical quality assurance or related environment is an advantage.
• Willingness to learn, take responsibility and apply quality requirements to decisions.

Responsibilities

• Connect with Clinical Supply Chain teams and global quality partners to gather information for release and QP certification.
• Support quality from the start by working with cross-functional teams and ensuring quality requirements in trial execution.
• Release of clinical trial materials by reviewing batch information and performing release activities.
• Progress toward broader Delegate QP responsibilities with experience.
• Apply GMP, GDP and trial requirements; guide operating teams accordingly.
• Assist with investigations of deviations, CAPAs, and risk mitigation with guidance from colleagues.
• Support audits and inspections readiness and maintain documentation.

Skills

Quality Assurance

Quality Standards

Data Analysis

Problem Solving

Compliance Management

Quality Management Systems

Internal Controls

Education

Industrial Pharmacist degree

Job description

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. 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.

Required Skills

Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards

Salary and Benefits

The anticipated base pay range for this position is: €60000,00 - €96255,00

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.
• 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
• service anniversary and recognition awards
• employees - and in some location’s eligible dependents - can participate in several insurance plans.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

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 https://www.jnj.com/. Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive.

Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.

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