Senior Quality Manager
Vor 3 Tagen
How you’ll Make an ImpactAct as Quality Management Representative / PRRC for the siteProvide strategic leadership and direction to the QA teamDrive compliance and excellence in quality, including NC / CAPA, change control, risk management, and complaint handling managementCollaborate closely with the site leadership team and product segment managers to deliver robust product quality improvement initiatives and enhance quality performanceChampion compliance and foster a strong culture of quality and GMP awareness, ensuring the site consistently meets all applicable standardsLead and coordinate all internal and external audits, including those conducted by health authorities, notified bodies, and customersSpearhead or actively contribute to projects focused on harmonizing and optimizing quality processes, working in partnership with Quality Assurance colleagues to achieve organizational objectivesBuild and maintain effective collaboration with other QA leaders to continuously strengthen and evolve the quality management systemWhat you bringAdvanced degree in Biology, Pharmaceutical Sciences, or a related field (BSc/MSc or equivalent)Deep knowledge of Quality Management Systems for in-vitro diagnostics and comprehensive understanding of national and international regulations (ISO 13485, QMSR / 21CFR820, MDSAP, IVDD/R)Minimum of 10 years’ experience in Quality Assurance within the medical device or healthcare industry, including hands-on experience in in-vitro diagnosticsDemonstrated managerial expertise with at least 8 years of experience leading and developing high‑performing teamsRecognized for leadership, interpersonal and negotiation skills, and a strategic mindset to create value from quality team activitiesProven commitment to meeting deadlines and delivering results in a dynamic environmentExtensive experience managing audits and regulatory inspectionsExperience in Lean or Six Sigma projects preferred; certification Lean / 6σ Green Belt would be a plusSolid background in quality project managementFluency in French; good command of German is an assetExcellent proficiency in English (international working environment)What We OfferCompetitive salaryCompany restaurantAnnual bonus & salary reviewHybrid working model (3 days on site and 2 days home office)Employee referral schemeContribution to fitness subscriptionEmployee assistance programmeTraining & development programs, with access to LinkedIn LearningIf you feel attracted by this unique opportunity and you would like to take on new challenges, we would like to get to know you. Please forward your complete application (application letter, CV, copies of work certificates and diplomas/degrees, etc.) to the address given in the advertisement. #J-18808-Ljbffr
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