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Job Description:

Within Johnson & Johnson Innovative Medicine, we are recruiting a Senior QA Associate for Investigational Medicinal Products (IMP) as member of our Clinical Supply Quality (CSQ) Operations Beerse drug product team based in Belgium. Our department CSQ is responsible for the release and certification of Investigational Medicinal Products used in worldwide clinical trials guaranteeing product quality and compliance with applicable regulations.

In the Janssen Research & Development area we develop treatments that improve the health and lifestyles of people worldwide. R& D development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, pulmonary hypertension and reproductive medicine.

As Senior QA Associate CSQ Operations Beerse drug product, you will support the clinical release and quality oversight process of IMPs (chemical and biological compounds) used in worldwide clinical trials so that patient safety and compliance with applicable regulations are warranted. Specifically, within the CSQ Operations Beerse Drug product sub team you will support the sterile clinical manufacturing activities in Beerse and the clinical release activities for Beerse manufactured and external drug products.

Key Responsibilities:

• Monitor and ensure compliance with Annex1 of parenteral manufacturing activities.
• Ensure that deviations and complaints are timely and properly investigated and adequate CAPA’s are defined for investigations with potential product quality impact.
• Lead/Drive quality in the organisation: Ensure quality is incorporated in the processes & functions.
• Ensure the operational quality performance by participating in different quality review meetings.
• Ensure that all changes that may have an impact on quality, compliance or registration are evaluated in order to execute adequate control, documentation, validation and qualification.
• Ensure in-depth investigations by providing technical, quality and compliance expertise.
• Take accountability of implementation and execution of different quality system processes.
• Work as One team with Quality and Clinical Supply Chain partners to ensure timely release and certification of clinical trial material in support of a reliable supply chain.
• Build a strong connection with other parenteral manufacturing sites in the network to continuously learn & share best practices.
• Ensure the quality oversight process of the operational activities by QA review and approval of GMP documentation.
• Ensure timely review of quality records such as batch record and confirmation of clinical trial material in order to support a reliable supply chain.
• Act as spokesperson during Health Authority inspections and customer audits.
• Support the in-house check rounds to verify the GMP compliance within the functional areas and support in preparation and execution of internal and external inspections.
• Continuously challenge the status quo and support the development and implementation of breakthrough innovative initiatives that deliver sustainable improvement in organizational, quality and compliance performance.

IT’S ALL ABOUT YOU

To be successful, you demonstrate the ability to communicate effectively at all levels within a virtual matrix environment. Further requirements include:

• University degree, scientific orientation (pharmaceutical, chemical, or biological sciences).
• At least 3 years cross functional experience in the pharmaceutical industry.
• Experience in pharmaceutical supply chain and/or Quality Assurance is an asset.
• Demonstrated ability to work independently while staying connected with key stakeholders.
• Operational Quality and/or Production related expertise is an asset.
• Product development expertise is an asset.
• Ability to prioritize, quickly assimilate new technologies and product knowledge, perform risk assessment and develop action plans.
• In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures.
• Understands the business implications regarding quality positions and decisions.

Closing date: Thursday, 12th of June 2025.

Are you ready to make an impact?

If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.

We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.