Inspection Manager
il y a 1 jour
Reports to: Head of Preclinical Quality & GxP audits and inspections
Main Responsibilities
- As argenx can face health authority inspections in all locations were argenx is present and has operational activities ongoing; cross functional global collaboration with multiple teams is key to ensure that inspection activities are planned and executed in accordance with internal procedures in order to maintain argenx inspection ready at all times.
- Deliver planning for inspection readiness activities, inspection management training, developing, and maintaining inspection management processes and development of inspection management tools and systems. Facilitate the needs of the inspection team for health authority inspections. Provide continuous awareness to argenx employees on inspection related matters, as and when needed.
- Provide through partnership with argenx Quality and related operational teams on health authority inspection and mock matters. Working with Global Quality, facilitate inspection readiness, requests for information/documentation, and inspection response activities. To stay on top of all inspection-related requests/actions/observations in order to streamline responses throughout different inspections.
- Maintain prediction of inspections and report status of health authority inspections. This includes reporting inspection activity, findings/observations, metrics, and relevant insights such as inspection history, SAE, etc. Assist in the preparation of inspection risk assessments for senior management and key stakeholders so they are apprised key risk prior to an inspection and that appropriate corrective action plans are implemented in a timely manner.
Desired Skills & Experience
- Pharmaceutical background preferred with strong knowledge of the global health authority regulations (e.g., FDA, EMA, PMDA); local requirements and GxP.
- Knowledge and experience of inspection management processes with ability to drive inspection preparedness and response actions.
- Strong communication, organization and networking skills.
- Excellence in leadership.
- 8+ years of experience in quality & compliance activities including audit and inspection support.
- 5+ years of experience in regulated industry or equivalent.
- Ability to travel up to 25%.
-
Clinical Operations Excellence Lead
il y a 1 jour
Gent, Belgique Argenx Temps pleinROLES AND RESPONSIBILITIES: - Ensure oversight of the adequacy of processes in Global Clinical Operations. Ensure regulatory requirements and commitments are reflected in the procedural documents - Identify and drive continuous improvement of processes and systems within Global Clinical Operations organization - Ensure quality risk management principles are...
-
Junior Property Manager Alinso Group
il y a 1 jour
Gent, Belgique ALINSO GROUP Temps plein**What's in it for you?**: You become part of a hands-on real estate company with outstanding career perspectives. The job offers a variety of challenging responsibilities. You’ll be part of a dynamic team that manages the facilities and properties, deploys improvements to the facilities and properties, and share input for new (re)developments. YOUR...
-
Clinical Data Manager
il y a 1 jour
Gent, Belgique Argenx Temps pleinFor the expansion of our Clinical Data Management team, argenx is looking for a Clinical Data Manager (CDM). Key Accountabilities/Responsibilities: The CDM is responsible for all data management aspects of the assigned clinical studies from initiation till closure ensuring that clinical data completeness, accuracy and consistency meet the standards of...
-
EHS Manager
il y a 1 jour
Gent, Belgique Argenx Temps pleinJoin us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to...
-
Warehouse Expansion Project Manager
il y a 1 semaine
Gent, Belgique 7555-Janssen Pharmaceutica NV Legal Entity Temps pleinWarehouse Expansion Project Manager page is loaded **Warehouse Expansion Project Manager**: **Job Function**: Supply Chain Deliver **Job Sub Function**: Warehouse & Distribution **Job Category**: Professional **All Job Posting Locations**: BE009 Turnhoutseweg 30, BE022 GENT **Are you inspired to make a big difference in the life expectancy of our...
-
Clinical Data Manager
il y a 1 jour
Gent, Belgique Argenx Temps pleinJoin us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to...
-
Clinical Data Standards Manager
il y a 1 jour
Gent, Belgique Argenx Temps pleinJoin us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to...
-
Clinical Operations Development Lead
il y a 1 semaine
Gent, Belgique argenx SE Temps pleinClinical Operations Development Lead page is loaded **Clinical Operations Development Lead**: The Clinical Operations Development Lead (CODL) is a key member of the Indication Development Team (IDT), overseeing clinical activities for a specific therapeutic indication (CODL) or across all indications for an asset (early/late phase CODL). The CODL provides...
-
Technicien / Technicienne de Maintenance (H/F/X)
il y a 1 semaine
Gent, Belgique Jobted BE C2 Temps pleinNous recherchons des Techniciens de Maintenance pour nos parcs éoliens en Belgique. ENVIRONNEMENT DU POSTE Vous serez rattaché hiérarchiquement au Responsable du Centre de Maintenance de Ghent. Et vous travaillerez en binôme. Le Centre de Maintenance auquel vous serez rattaché sera composé de plusieurs techniciens. MISSIONS DU POSTE Votre mission...
-
Support Manager Quality
il y a 1 jour
Gent, Belgique ArcelorMittal Temps pleinIntroduction Chaque année Eurogal produit environ 500.000 tonnes d’acier galvanisé qui sont livrées dans 37 pays à travers le Monde, en ce compris l’ensemble des constructeurs automobiles européens. Depuis son démarrage, Eurogal a produit plus de 8 millions de tonnes, ce qui représente, en poids, l’acier contenu dans 10.000.000 de voitures....
