QS Associate Risk Management
il y a 5 jours
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 Job Function: Quality Job Sub Function: Quality Systems Job Category: Professional All Job Posting Locations: Antwerp, Antwerp, Belgium, BE004 Antwerpseweg 15 17, BE005 Merksem, BE006 Geel, BE007 Olen, BE009 Turnhoutseweg 30, BE017 Turnhout, BE021 ACT Antwerp, Belgium, BE022 GENT, BE023 BE Gent Suzanne Tassierstraat, BE024 Ghent Techlane, Beerse, Antwerp, Belgium, Geel, Antwerp, Belgium, Gent, East Flanders, Belgium, Ghent, East Flanders, Belgium, Merksem, Antwerp, Belgium, Turnhout, Antwerp, Belgium, Zwijnaarde, Belgium, Zwijnaarde, East Flanders, Belgium Job Description: Within J&J Innovative Medicine Advanced Therapies Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a QS Associate Risk Management (M/F/X). As member of our Quality team coordinating the Quality Systems (QS) processes, you will be based in Ghent, Belgium or Beerse, Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient's own immune system. They are created from the patients' own T cells and are engineered to eliminate cancer cells expressing a specific antigen. J&J Innovative Medicine Advanced Therapies Supply Chain serves as Centre of Excellence for the manufacturing of CAR-T drug product for clinical and commercial purposes. The EMEA CAR-T Drug Product Supply Chain has two manufacturing sites in Ghent (Obelisc & Tech Lane) and the Cryo & QC activities in Beerse, Belgium. As QS Associate Risk Management, you are Subject Matter Expert on the risk management framework. You drive the implementation at the Ghent Obelisc, Ghent Tech Lane & Beerse sites and ensure adherence to the process. In this role you report directly to the Quality Systems Manager CAR-T. Key Responsibilities: * Implementing an integrated risk management framework in collaboration with key stakeholders and compliant with applicable regulations and J&J quality requirements. * Identifying key risks related to products, processes and systems with input from different angles including local and global functions of J&J Innovative Medicine, our collaboration partner Legend Biotech, suppliers, Health Authorities, etc. * Collaborating cross-functionally to assess identified risks and develop risk mitigation plans. * Supporting the organization in implementing risk mitigation plans. * Monitoring and reporting on the progress and resolution of risk management activities, effectively maintaining oversight over all risk management activities. * Ensuring risk management activities are appropriately recorded, allowing end-to-end traceability. * Acting as process owner for the risk management process: + Ensuring the process is suitable, adequate and effective. + Ensuring necessary documentation (procedures, instructions, templates, etc.) is established and readily available for the organization. + Ensuring effective training and support is provided to the organization. + Evaluating trends and defining appropriate actions. + Following up and completing corrective and preventive actions related to the process. + Ensuring and maintaining a state of inspection readiness. + Participating as spokesperson and/or Subject Matter Expert in audits and inspections. Qualifications Education: Master Scientific degree with a technical specialization in analytics / chemistry / biotechnology / pharmaceutical sciences / engineering (or equivalent through experience). Experience and Skills: Required: * 2-3 years of experience within Quality Systems or Quality Assurance in a GMP environment. * In-depth understanding of relevant pharmaceutical legislation / cGMP regulations. * Up-to-date knowledge of risk management standards and guidelines (e.g., ICH Q9, ISO 31000). * Strong analytical thinking and decision-making abilities, with a keen attention to detail. * Highly organized, capable of managing multiple tasks in a team environment, and able to work effectively under minimal supervision while maintaining a positive attitude. * Ability to work in a flexible way under time pressure in local and global teams. * Excellent verbal and written communication skills to effectively negotiate and interact with both external and internal customers and partners. Preferred: * Experience with data analysis and continuous improvement methodologies. * Experience with Health Authority inspections. Other: * You speak and write English fluently.
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il y a 3 semaines
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