Senior Quality Lead – Clinical Activities

il y a 3 semaines


Walloon Brabant Province, Belgique Nalys Temps plein

Senior Quality Lead – Clinical ActivitiesBrussels & Brabant‐Wallon Area, Belgium (Hybrid)About NalysNalys is a consulting group specialized in advanced engineering and life sciences. We partner with innovative organizations across the pharmaceutical and biotech sectors to help them accelerate projects, strengthen quality operations, and bring therapies to patients faster.Joining Nalys means joining a dynamic, people‐oriented community where expertise, collaboration, and personal growth are at the heart of everything we do.The OpportunityFor one of our key partners in the pharmaceutical industry, located near Brussels, we are looking for an experienced Senior Quality Lead to reinforce a growing Quality organization.In this strategic role, you will support GCP‐focused vendor qualification activities, lead Quality Agreement lifecycle management, and contribute to risk‐based oversight for a broad network of clinical vendors. You will act as a senior Quality partner, ensuring inspection readiness and full compliance with international regulations.This position is ideal for someone with strong GCP seniority who enjoys both autonomy and cross‐functional collaboration in a fast‐moving environment.Your ResponsibilitiesAs Senior Quality Lead, you will:Manage and perform GCP vendor qualification activitiesEnsure continuous inspection readiness and compliance with international GCP expectationsServe as QA point of contact for deviations, investigations, and audit observations related to assigned vendorsLead the setup, review, update, and closure of Quality AgreementsCollaborate closely with internal teamsSupport risk‐based oversight activities, including governance meetings, performance follow‐up, and issue escalationMaintain strong relationships with vendor organizations to ensure operational and compliance excellenceContribute to harmonization initiatives within the Quality organizationHelp identify process improvements and digitalization opportunities.Your ProfileYou have a minimum of 10 years of relevant experience in GCP QualityYou act as an expert in vendor qualification, vendor management, and Quality AgreementsYou have a strong understanding of clinical trial operations & GCP regulatory expectationsYou act as an expert in CAPA management, risk‐based oversight, and inspection readinessYou have an excellent command of English (working language).You are able to navigate digital tools and modern quality systemsStrong judgment, autonomy, and the ability to manage complex situations.Recruitment ProcessBy applying to the position of "Senior Quality Lead", here are the different you will go trough during the recruitment process:First Olivia Braszko, our Talent Acquisition Specialist will take contact with you for a first screeningThe second step will be a technical interview with on of our QA expertsTo finish the process, you will have an interview with the Director of Life Sciences BU, Jimmy Rousseaux.Interested?If you want to make a strong impact in the clinical quality landscape while contributing your expertise to a growing Quality team, we'd love to hear from you.Apply now and join the Nalys community



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