QA Manager, Clinical Supply Chain Operations
Change lives for the better.
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/.
THE OPPORTUNITY
How you can help.
Within Johnson & Johnson Innovative Medicine, we are recruiting a Quality Manager for Investigational Medicinal Products (IMP) as member of our QA-Clinical Supply Chain team based in Belgium.
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.
Our department QA-CSC is responsible for the release and certification of Investigational Medicinal Products used in worldwide clinical trials guaranteeing product quality and compliance with applicable regulations.
As Manager QA-CSC, 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 QA CSC Operations Beerse sub team you will support the sterile clinical manufacturing activities in Beerse and the clinical release activities for Beerse manufactured and external products.
What you’ll do.
Key activities include, but are not limited to:
- Act as QA CSC subject matter expert for aseptic manufacturing.
- Act as back-up team lead by mentoring and coaching the team.
- Act as Quality lead for the ongoing projects in the parenteral manufacturing area (i.e. introduction new parenteral filling line, realization of the new improved building layout, etc.) ensuring quality by design throughout the process.
- Ensure the operational quality performance by participating in different quality review meetings.
- Ensure that deviations and complaints are timely and properly investigated and adequate CAPA’s are defined for investigations with potential product quality impact.
- Ensure that all changes that may have an impact on quality, compliance or registration are evaluated to execute adequate control, documentation, validation, and qualification.
- Ensure in-depth investigations by providing technical, quality and compliance expertise.
- Act as spokesperson during Health Authority inspections and customer audits.
- 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 to support a reliable supply chain.
- Take accountability of implementation and execution of different quality system processes.
- 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.
- 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.
