[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"project-ivd-product-lead-external-manufacturing":3,"similar-ivd-product-lead-external-manufacturing":35},{"id":4,"slug":5,"title":6,"skills":7,"budget":20,"duration":21,"location":22,"onsitePercent":23,"contractType":24,"foundAt":25,"category":26,"description":30,"rawText":31,"language":32,"projectId":33,"sourceUrl":34},5099,"ivd-product-lead-external-manufacturing","IVD Product Lead External Manufacturing",[8,9,10,11,12,13,14,15,16,17,18,19],"IVD product management","ISO 13485","IVDR","FDA 21 CFR","Product specification","Production process specification","Leadership","German","English","Engineering","Natural Science","OPEX\u002FCAPEX",null,"12++ months","Rotkreuz",90,"temp_work","2026-05-21T12:06:25+00:00",{"id":27,"slug":28,"label":29},14,"medical_tech","Medizintechnik","Product Lead für externe Fertigung bei einem großen Pharmaunternehmen in Rotkreuz. Verantwortung für IVD-Produktmanagement, Produktspezifikationen, Lieferantenmanagement und interdisziplinäre Teamführung. Erfordert Erfahrung in IVD-Produktmanagement und Kenntnisse in ISO 13485, IVDR, FDA 21 CFR.","IVD Product Lead External Manufacturing\n\ntemporary\nIVD Product Lead External Manufacturing\nProduct Lead External Manufacturing: IVD product management \u002F ISO 13485 \u002F IVDR \u002F FDA 21 CFR \u002F OPEX\u002FCAPEX \u002F German \u002F English\nProject:\nFor our customer a big pharmaceutical company in Rotkreuz we are looking for a highly qualified Product Lead External Manufacturing\nBackground:\nGlobal External Manufacturing is the competence center for parts and products in the diagnostic workflow, manufactured by external suppliers. This includes the development of new products, product care activities, the assurance of supply as well as the supplier selection and maintenance in close collaboration with Procurement.\nThe Perfect Candidate:\nAs Product Lead you are the focal point for your designated products and work in an interdisciplinary team ensuring a holistic view of necessary activities. In this position you have versatile and varied responsibilities interacting with our Suppliers, Supply Chain, Quality and Regulatory as well as System Development and Business Management ensuring continuous learning and development. Together with the team members you have the possibility to exercise your leadership, enfolding the swarm intelligence of the people surrounding you. The need to visualize complex interdependencies for fact based decision making, ensures ample opportunity to use your communication and presentation skills.\nTasks & Responsibilities:\n* Accountable for assigned products\n* Is accountable for Product- \u002FProduction-issues and risks\n* Owner of product specification and production process specification\n* Accountable for product changes, complaints and deviations\n* Accountable for spare part management\n* Accountable for production assets and equipment\n* Accountable for the overall Squad performance with regards to quality, supply, compliance, cost\n* Ensures a clear, strategic Squad view on prioritization and OneRoche mindset\n* Develops and implements the product wide production capacity plan and output report in collaboration with the relevant functions in accordance with the Product Strategy and provides information to Network Lead\n* Acts as the final decision maker within Squad e.g. prioritization\n* Manages all key stakeholders at Squad level (internal and external)\n* Represents Global External Manufacturing in Business Teams on PCQT level, represents Global External Manufacturing in system development projects\n* Interacts with business (e.g. IPM) to understand demand forecast, its development and fluctuations and triggers follow up actions\n* Compiles Annual Product Review Report in collaboration with all relevant stakeholders, including triggering actions, risks and mitigations\n* Chairs Product Meeting with supplier and sub-suppliers at an operative level\n* Chairs the Squad and provides necessary leadership to the team members to assume their responsibilities\n* Responsible for Squad budget (e.g. OPEX\u002FCAPEX, development budget, PCQT budget)\n* Manages SMC cost account including budget planning and search for potential savings\n* Provides feedback to Chapter Leads on Squad Members\n* Executes Operative Risk Management\n* Plans replacements and new investments and calculates business cases\n* Understands contracts with suppliers with regards of content\n* Monitors the supplier safety stock and the Roche hub stock versus targets\n* Owns and maintains product documentation during Product Life Cycle\nMust Haves:\n* University degree in Engineering, Natural Science or related disciplines\n* Min. 3 years of work experience in IVD product management and production engineering\n* Ability to think strategically and systemically, willingness to try new ideas and participate in changes\n* Leadership experience and skills, including the ability to get things done with a proven track record of consensus building and conflict management in challenging situations\n* Self-motivated, autonomous, structured and goal-oriented mindset with a solution oriented balance of short term mitigation and long term solution\n* Ability to effectively communicate with all levels of the organization by establishing credibility and building rapport\n* Executive presence where you perform well under pressure and with decisiveness\n* Excellent communication skills in German and English\n* Travel required 10(-20)%\nNice to Haves:\n* Experience in IVD product development following design control, manufacturing and testing\n* Knowledge of Process Management methodologies (Lean, Six Sigma, etc.) and in-vitro diagnostic related regulations, such as ISO 13485, IVDR, FDA 21 CFR part 820etc.\nReference Nr.: 924863SDA\nRole: Product Lead External Manufacturing\nIndustrie: Medical\nWorkplace: Rotkreuz\nPensum: 90 – 100%\nStart: ASAP\nDuration : 12++ months\nDeadline : 29.05.2026\nIf you are interested in this position, please send us your complete dossier. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.\nContact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.\nAbout us: ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.\nWe offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.\nApply Now\n\nIndustry\nPharmaceuticals\nLocation\nZug\nType\ntemporary\n\nE-Mail: service@itcag.com","en","924863SDA","https:\u002F\u002Fwww.itcag.com\u002Fjobs\u002Fivd-product-lead-external-manufacturing-8079\u002F",{"items":36},[37,55,74,94,109,128,151,165,183,197,215,230,245,256,274],{"id":38,"slug":39,"title":40,"skills":41,"budget":20,"duration":50,"location":20,"onsitePercent":51,"contractType":52,"foundAt":53,"category":54},5005,"cmc-regulatory-expert-mwd-fokus-peptid-parenterale-originalpraeparate-2","CMC Regulatory Expert (m\u002Fw\u002Fd) – Fokus Peptid \u002F parenterale Originalpräparate",[42,43,44,45,46,47,48,49],"CMC-Dokumentation","Originalpräparate","parenterale Peptid-Produkte","Modul 3 (Quality)","Regulatory Affairs","EMA\u002FFDA Anforderungen","Dossier-Erstellung","Manufacturing Change Control","bis mindestens 31.12.2026 (Option auf Verlängerung)",50,"contracting","2026-05-21T08:16:18+00:00",{"id":27,"slug":28,"label":29},{"id":56,"slug":57,"title":58,"skills":59,"budget":20,"duration":70,"location":71,"onsitePercent":51,"contractType":52,"foundAt":72,"category":73},5004,"senior-analytical-scientist-hplcuhplc-biologics-2","Senior Analytical Scientist (HPLC\u002FUHPLC, Biologics)",[60,61,62,63,64,65,66,67,68,69],"HPLC","UHPLC","Chromatographie","Biologics","Proteinbiochemie","Methodenentwicklung","Thermo Fisher UHPLC-Systeme","Chromeleon Software","SEC","RP","ca. 9 Monate","Österreich","2026-05-21T08:16:11+00:00",{"id":27,"slug":28,"label":29},{"id":75,"slug":76,"title":77,"skills":78,"budget":20,"duration":20,"location":90,"onsitePercent":91,"contractType":52,"foundAt":92,"category":93},4585,"laborant-zellkultur-mwd","Laborant Zellkultur (m\u002Fw\u002Fd)",[79,80,81,82,83,84,85,86,87,88,89],"Anlagen","Auswertung","Entwicklung","Fermentation","GMP","Herstellung","Optimierung","Planung","Teamfähigkeit","Zellkultur","Zelllinien","Biberach an der Riß",100,"2026-05-20T02:26:18+00:00",{"id":27,"slug":28,"label":29},{"id":95,"slug":96,"title":97,"skills":98,"budget":20,"duration":20,"location":90,"onsitePercent":91,"contractType":52,"foundAt":107,"category":108},4550,"technischer-assistent-hplc-analytik-mwd","Technischer Assistent HPLC-Analytik (m\u002Fw\u002Fd)",[60,83,99,100,101,102,103,104,105,106],"Analytik","Methodenvalidierung","Dokumentation","Empower","LabWare-LIMS","MS-Office","Chemielaborant","Biologielaborant","2026-05-19T16:25:57+00:00",{"id":27,"slug":28,"label":29},{"id":110,"slug":111,"title":112,"skills":113,"budget":20,"duration":124,"location":125,"onsitePercent":23,"contractType":52,"foundAt":126,"category":127},4527,"project-engineer-mwd-pharma","Project Engineer (m\u002Fw\u002Fd) Pharma",[114,115,116,117,118,119,120,121,122,123],"Projektmanagement","GMP-Kenntnisse","Pharmazeutische Industrie","Verfahrenstechnik","Biotechnologie","Pharmatechnik","Chemieingenieurwesen","Maschinenbau","Englischkenntnisse","Kommunikationsfähigkeit","6 Monate","Ludwigshafen am Rhein","2026-05-19T14:35:32+00:00",{"id":27,"slug":28,"label":29},{"id":129,"slug":130,"title":131,"skills":132,"budget":20,"duration":147,"location":148,"onsitePercent":91,"contractType":52,"foundAt":149,"category":150},4515,"testing-von-medizingeraeten","Testing von Medizingeräten",[133,134,135,136,137,138,139,140,141,142,143,144,145,146],"Testing","Testspezifikation","Jira","Python","C","C#","SQL","ISTQB","Elektronik","Informatik","Requirements Management","Polarion","Netzwerk","Datenbanken","13 Monate","Bensheim","2026-05-19T14:26:47+00:00",{"id":27,"slug":28,"label":29},{"id":152,"slug":153,"title":154,"skills":155,"budget":159,"duration":160,"location":161,"onsitePercent":162,"contractType":52,"foundAt":163,"category":164},4422,"mfc-und-c-entwickler-fuer-medizinischen-bereich","MFC und C++ Entwickler für medizinischen Bereich",[156,157,158],"C++","MFC","Reportstellung","auf Anfrage","3 Monate +","Ingolstadt",10,"2026-05-19T09:30:24+00:00",{"id":27,"slug":28,"label":29},{"id":166,"slug":167,"title":168,"skills":169,"budget":20,"duration":179,"location":180,"onsitePercent":20,"contractType":24,"foundAt":181,"category":182},3781,"validation-manager-ingenieur-reinigungs","Validation Manager \u002F Ingenieur Reinigungs",[170,171,172,173,174,83,118,175,176,177,178],"Validierung","Qualifizierung","Sterilisationsvalidierung","Reinigungsvalidierung","Anlagenqualifizierung","Pharma","Veeva","eVAL","Autoklaven","9+ Monate","Basel","2026-05-19T08:46:18+00:00",{"id":27,"slug":28,"label":29},{"id":184,"slug":185,"title":186,"skills":187,"budget":20,"duration":147,"location":194,"onsitePercent":51,"contractType":52,"foundAt":195,"category":196},3733,"entwicklung-sensorsysteme","Entwicklung Sensorsysteme",[101,141,81,188,123,189,190,29,191,171,192,193,170],"Forschung und Entwicklung","Koordination","Medizinprodukte","Messtechnik","Software","Umsetzung","Mannheim","2026-05-19T08:26:47+00:00",{"id":27,"slug":28,"label":29},{"id":198,"slug":199,"title":200,"skills":201,"budget":20,"duration":212,"location":180,"onsitePercent":20,"contractType":24,"foundAt":213,"category":214},3684,"analytical-project-leader","Analytical Project Leader",[60,202,203,204,205,206,207,208,209,210,211],"UPLC","ICH-compliant method validation","cGMP","Small molecule drug development","Stability studies","Impurity profiling","Regulatory documentation","IND\u002FNDA","Analytical chemistry","Ph.D. or Master's degree","12+ months","2026-05-19T04:49:29+00:00",{"id":27,"slug":28,"label":29},{"id":216,"slug":217,"title":218,"skills":219,"budget":20,"duration":226,"location":180,"onsitePercent":91,"contractType":227,"foundAt":228,"category":229},3682,"verfahrensingenieur-fuer-biotechnologische-produktionsanlagen","Verfahrensingenieur für biotechnologische Produktionsanlagen",[117,118,83,220,221,175,222,223,114,224,225],"Upstream","Downstream","Process Engineering","Betriebsengineering","Deutsch","Englisch","12++ Monate","permanent","2026-05-19T04:49:18+00:00",{"id":27,"slug":28,"label":29},{"id":231,"slug":232,"title":233,"skills":234,"budget":20,"duration":212,"location":180,"onsitePercent":20,"contractType":24,"foundAt":243,"category":244},3679,"analytical-compliance-record-specialist","Analytical Compliance Record Specialist",[235,236,83,237,238,239,240,241,60,242],"Organic Chemistry","Analytical Chemistry","Quality Control","CAPA","Deviations","Change Control","Veeva Vault","Mass Spectrometry","2026-05-19T04:48:59+00:00",{"id":27,"slug":28,"label":29},{"id":246,"slug":247,"title":248,"skills":249,"budget":20,"duration":253,"location":180,"onsitePercent":20,"contractType":24,"foundAt":254,"category":255},3678,"quality-control-project-lead","Quality Control Project Lead",[237,83,204,236,250,60,251,242,252,16],"LIMS","Gas Chromatography","Waters Empower","12 months","2026-05-19T04:48:54+00:00",{"id":27,"slug":28,"label":29},{"id":257,"slug":258,"title":259,"skills":260,"budget":20,"duration":212,"location":22,"onsitePercent":20,"contractType":24,"foundAt":272,"category":273},3673,"validation-engineer","Validation Engineer",[261,262,263,264,265,9,266,267,268,269,270,271,15,16],"Validation","Qualification","Auditing","Quality functions","MDR","21 CFR 820","External Manufacturing","Blow Molding","Injection Molding","Process Risk Analysis","Statistical Data Analysis","2026-05-19T04:48:20+00:00",{"id":27,"slug":28,"label":29},{"id":275,"slug":276,"title":277,"skills":278,"budget":20,"duration":226,"location":22,"onsitePercent":91,"contractType":227,"foundAt":286,"category":287},3664,"maschinenfuehrer-anlagenfuehrer-mwd","Maschinenführer \u002F Anlagenführer (m\u002Fw\u002Fd)",[279,115,280,281,282,283,284,285],"Anlagenbedienung","SAP","Siebdruck","Dispensierung","Produktionserfahrung","3-Schicht-Bereitschaft","Deutschkenntnisse C1","2026-05-19T04:46:51+00:00",{"id":27,"slug":28,"label":29}]