Delegate Qualified Person Clinical Supply Quality

pAt 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 . /ppAs 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. /ppbJob Function: /b /ppQuality /ppbJob Sub Function: /b /ppQuality Assurance /ppbJob Category: /b /ppProfessional /ppbAll Job Posting Locations: /b /ppBeerse, Antwerp, Belgium /ppbJob Description: /b /ppDo 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 bDelegate Qualified Person /bin RDQA
- Clinical Supply Quality. You will work at the heart of global clinical supply chains for synthetics, biotherapeutic molecules and advanced therapy medicinal products (ATMPs). /ppEvery 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. /ppThis 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? /ppbWhat you can expect from this role /b /ppbMeaningful impact: /b help clinical trial materials reach patients safely and on time. Advancing medicines into commercialization. /ppbYou will operate in a dynamic, fast
- /bpaced environment where agility and out-of-the box thinking are valued /ppbA steep learning curve: /b gain hands-on exposure to different products, technologies, supply chains, worldwide regulatory expectations and different leadership levels.bReal ownership: /b make and defend quality decisions, lead investigations and see your improvements put into practice. /ppbGlobal collaboration: /b work with multidisciplinary teams and external partners across Europe and the US. /ppbVisibility and growth: /b 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. /ppbChallenge status quo: /b challenge existing processes and turn good ideas into sustainable solutions. /ppbWork outside existing frameworks: /b 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. /ppbWhat you will do /b /ppbBring the right experts together: /b work closely with Clinical Supply Chain teams and global quality partners to secure the input needed for timely release and QP certification. /ppbInfluence quality from the start: /b represent Clinical Supply Quality in cross-functional teams and ensure quality requirements are built into clinical trial execution. /ppbRelease clinical trial materials: /b review batch information and perform release activities within the Janssen RD IMP license, helping to keep clinical studies supplied. /ppbTurn regulations into practical guidance: /b advise and coach operational teams on GMP, GDP and clinical-trial requirements. /ppbSolve real quality issues: /b guide timely investigations of deviations and complaints, help define effective CAPAs and elevate potential patient or supply risks appropriately. /ppbImprove the system: /b own selected quality-system processes, challenge the status quo and implement sustainable improvements. /ppbRepresent your expertise: /b act as a QA spokesperson during customer audits and Health Authority inspections. /ppbWhat you bring /b /ppbRequired: /b a university industrial pharmacist degree and qualification as EU-certified Qualified Person residing in Belgium. /ppAt least three years of experience in pharmaceutical supply chain, quality assurance or a closely related environment. /ppAn interest in taking ownership, learning quickly and applying quality requirements to practical decisions. /ppExperience with product release is an advantage, but we also value relevant operational quality or production experience. /ppbHow you will thrive /b /ppYou understand pharmaceutical production and quality systems; knowledge of sterile manufacturing is an advantage. /ppYou can work with cGMP, ICH guidelines and internal standards, and translate them into clear, ris