Senior Quality Systems Architect (m/f/d)

ppbSenior Quality Systems Architect (m/f/d) /b /p /pliBasel /liliBerlin /li liGreifswald /li liRemote /liliPräsenz / Mobil /liWe are an owner-managed, globally active company in the specialty pharmaceuticals sector with a clear mission: to be THE bsustainable platform /b for long-established and trusted pharmaceutical brand products in various therapeutic areas. As a breliable partner /bto the research-based pharmaceutical industry, CHEPLAPHARM ensures the availability and supply of these medicines for the global market.br/br/This benefits not only our partners, but also patients around the world. We are proud that our specialised business model has enabled us to become one of the world's leading companies in the acquisition of original preparations within 20 years, and we continue to grow. The aspiration of our approximately 800 employees: Together, we want to ‘bACHIEVE MORE /b’.ppbWhat makes your day with us special: /b /p /p liDesign and further develop the global Quality Management System, including processes for deviations, CAPA, and documentation /li liImplement, validate, and continuously improve electronic quality systems (eQMS) and related platforms /li liMaintain and continually improve existing quality systems to ensure compliance with regulatory requirements. /li liEnsure alignment with relevant international GxP regulations, such as ICH Q10, EU GMP/GVP/GCP/GDP, 21 CFR, and Regulatory regulations /li liEnsure compliance with international GxP regulations and drive data integrity initiatives across quality systems /li liCoordinate cross-functional stakeholders and lead interactions with regulatory authorities and external partners /li liAnalyze existing processes, define improvement measures, and contribute to strategic quality system development /li ppbWhat sets you apart: /b /p /p liA Master’s degree in a relevant field, i.e. generally in the natural sciences, pharmacy or medicine /li liAt least 7 years of relevant professional experience. /li liStrong expertise in electronic Quality Management Systems, including validation and data integrity /li liExpert knowledge of GxP (GMP, GVP, GDP, GCP) and computer system validation (CSV) or ISPE GAMP5. /li liProven experience in cross-functional collaboration and stakeholder management in complex environments /li liAnalytical and strategic mindset with the ability to drive innovation and continuous improvement in quality systems /li ppbWhat we offer you besides the job: /b /p /ppbCorporate culture internationality /bbr/A growing company with a diverse, open working environment and employees from around 40 countries.br/br/bFlexible working models work-life balance /bbr/Individually customisable working models, including the option to work from another EU country for up to two months per year. Working time account with compensatory time off and 30 days of holiday.br/br/bIndividual benefits pension provision /bbr/Flexible benefits budget, e.g. for increased company pension provision, fitness and health offers or subsidies for travel and meal costs.br/br/bDiscounts additional benefits /bbr/Access to the corporate benefits platform with discounts at hundreds of partner companies.br/br/bFurther development team culture /bbr/Internal and external training courses tailored to personal goals, as well as company and team events to strengthen cohesion and celebrate successes together.br/br/We look forward to receiving your detailed application! Please only use the ‘bApply now! /b’ function to submit your application. /pppbYour contact person: /b /p /pliDaniel Grabowski /liliHead of HR Recruiting /li #content_zone { max-width: 834px; } #scheme_detail_data { width:100%; display:table; margin-bottom: 10px; } .scheme-border { border: 1px solid rgba(220,223,226,0.8); } .scheme-margin { margin-top: 10px; } .scheme-display .scheme-content { font-size: 16px; padding: 14px 24px; background-color: #ffffff; line-height: 1.6; } .scheme-display .scheme-title { word-break: break-word; } .scheme-display .scheme-title h2 { margin: 0px; font-size: 28px; line-height: 2; padding: 0px; } .scheme-display .scheme-title ul { margin-bottom: 16px; } .scheme-display .video { width: 100%; height: 400px; } .scheme-display h2.scheme-headline { margin: 0px 0px 18px 0px; padding: 0px; } .scheme-display .content-images { position: relative; overflow: hidden; display: block; box-sizing: border-box; padding: 0px; } .scheme-display .content-images:not(:has(.content-images-frame)) { height: 335px; } #header_image { display: none; } #jobTplContainer ul.scheme-additional-data { margin-bottom: 0px; min-width: 40%; } .scheme-additional-data { float: left; margin: 0; padding: 0; list-style: none; } .scheme-additional-data li { list-style: none; margin: 4px 15px 0px -3px !important; } .scheme-additional-data li.left { float: left; } .scheme-display .slide-images:nth-child(2), .scheme-display .slide-images:nth-child(3) { display:none; } .scheme-display .slide-images { width: 100%; position:absolute; top: 50%; left: 50%; -webkit-transform: translate(-50%,-50%); -ms-transform: translate(-50%,-50%); } .scheme-display .content-images-frame { position: relative; width: 100%; height: 335px; overflow: hidden; } .scheme-display .content-images-description { display: block; text-align: left; font-size: 1rem; line-height: 1.4; color: #000; padding: 8px 24px; border-bottom: 1px solid rgba(220,223,226,0.8); } .scheme-content .user-image { width: 100px; height: 100px; border-radius: 50%; float: left; line-height: 100px; background: no-repeat center center; background-size: cover; } .scheme-content .user-data { height: 100px; margin-left: 80px; } .scheme-content .user-data li { list-style: none; } i.fa-fw { margin-right: 5px; margin-left: 5px; } @media (max-width: 768px) { .scheme-additional-data li { display: block; float: none; } .scheme-display .content-images { height: 250px; } } @media (max-width: 650px) { .scheme-display .content-images { height: 250px; } } @media (max-width: 450px) { .scheme-display .content-images { height: 133px; } } #frame_zone { background-color: #ffffff; }