Responsable Projets Qualité H/F

Join to apply for the Responsable Projets Qualité H/F role at LFB2 weeks ago Be among the first 25 applicantsJoin to apply for the Responsable Projets Qualité H/F role at LFBOverviewDirectly attached to the Quality Management, Arras site, which will meet global quality standards (FDA & EMA) in operation. You are a member of the site Quality Management Committee.ResponsibilitiesYou are responsible for the Quality Readiness of development projects (new products and markets) as well as site or intersite projects that may have an impact and require alignment. You act as the Quality and Regulatory representative of the site in site Project Committees to ensure regulatory requirements are addressed.You represent the site Quality function in global programs, acting as a relay between local Operations and Group level bodies. You provide expertise in the review of regulatory dossiers (PACMP, Type C, CTD, BLA…) and in responses to questions following regulatory assessment of a file or a Health Authority inspection.You are responsible for mapping Quality risks from site projects to feed into Inspection Readiness and Quality Risk Management processes.Facilitate the operational link between site SME métiers and global teams in France, Europe and the US (Scientific Medical & Regulatory Affairs, Global Project Development Leaders, Regulatory Project Managers, Industrial Teams, Programme Industrialisation, Industrial Product Leader).Represent site Quality inGroup COPILs for product development projects and strategic projects.Support identification and tracking of pre-requisites to PPQ and escalation process to the site Quality Management for decision making through defined bodies.Report Inspection risks and define action plans with métiers, experts and global teams to ensure alignment between site practices.Participate in site project COPILs to provide support in interpreting regulatory requirements.Monitor the delivery of deliverables for dossier submissions and run follow-up meetings for the site.Identify gaps to applicable regulatory requirements.Organize and lead intra- and intersite working meetings to raise a common position or support decision-making.QualificationsPROFILE FOR THIS OPPORTUNITYPharmacist with industry specialization or Doctor in biology, or Engineer with a science/biology/chemistry focus (additional training in project management or business management is a plus). You have proven experience in cross-functional project management and more than 15 years of experience in the pharmaceutical/biotechnology industry in an FDA and aseptic environment, in Quality and Industrial roles.Experience with FDA, Europe and International Inspections and Reference frameworksAdvanced project management skills, results orientationPositive leadershipAbility to decide and persuadeStrong communication skillsFluent EnglishBenefitsPermanent contract (CDI)Remote work: up to 2 days per week after 4 months tenureRTT: 7 to 9 days + 3 additional leave daysTransport allowance: 50% of transport card or monthly allowance depending on residenceMutual insurance, Provident, PEG/PERE-CO with employer contributionTime Savings AccountChildcare facility placesDiscount on a sports club membershipSeniority levelMid-Senior levelEmployment typeFull-timeJob functionProject Management and Information TechnologyIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at LFB by 2xGet notified about new Quality Assurance Project Manager jobs in Arras, Hauts-de-France, France. #J-18808-Ljbffr