Senior Manager Quality Management Devices and Combination Products (m/f/d)

14.04.2021

Daten dieser Anzeige

Job-ID: 021229947
Senior Manager Quality Management Devices and Combination Products (m/f/d)

Fresenius Kabi

Germany

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Manage and coordinate internal and external Change Controls, Events, Complaints, CAPAs, etc. related to Medical Devices, Packaging Components and Combination Products Maintain an electronic Quality Management System to host device related technical documentation, such as Technical File, Design History File and related Design Control Documentation throughout the product lifecycle. Lead device control specific activities e.g. Risk Management, Management Reviews in accordance with applicable quality standards and guidelines Support the preparation of the device sections for BLA and MAA submissions Support device projects during the development, in the planning process and in the preparation of documentation to ensure compliance with required quality standards and regulations Actively supports the selection and qualification of device suppliers during the development and support the device suppliers audit by the production unit Conduct internal quality reviews and self-inspections Maintain an up-to-date knowledge of device regulations and standards applicable especially in the USA and EU and implement requirements into locally applicable procedures (SOPs, Guiding Documents, Working Instructions, etc) Establish a QMS for device activities within FKSBS in accordance with applicable standards and regulations Manage GMP/MDR/GDP quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriers by Planning and executing vendor audits, including monitoring of CAPA progresses till completion Negotiate, establish and maintain quality agreements Perform Gate Reviews for PPQ readiness On-site presence during critical activities (e.g. PPQ campaign, Tech Transfer, HA inspections) Define KQIs/KCIs, collect data for periodic management review to identify Risks and mitigate Ensure Inspection readiness of Medical Device Vendors and CP CMOs Manage GMP compliance during Tech Transfer of manufacturing, assembly, testing and packaging of Combination Product by Authoring, reviewing, approving, as applicable, protocols, plans and reports (e.g. Validations) Identify the risks and establish appropriate mitigation plan Contribute to QM programs and GMP/MDR/GDP compliance activities as appropriate

About Fresenius / CAREER WITH A PURPOSE / Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients. Senior Manager Quality Management Devices and Combination Products (m/f/d)  With our corporate philosophy of «caring for life», we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face. In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients. Your assignments Manage and coordinate internal and external Change Controls, Events, Complaints, CAPAs, etc. related to Medical Devices, Packaging Components and Combination Products Maintain an electronic Quality Management System to host device related technical documentation, such as Technical File, Design History File and related Design Control Documentation throughout the product lifecycle. Lead device control specific activities e.g. Risk Management, Management Reviews in accordance with applicable quality standards and guidelines Support the preparation of the device sections for BLA and MAA submissions Support device projects during the development, in the planning process and in the preparation of documentation to ensure compliance with required quality standards and regulations Actively supports the selection and qualification of device suppliers during the development and support the device suppliers audit by the production unit Conduct internal quality reviews and self-inspections Maintain an up-to-date knowledge of device regulations and standards applicable especially in the USA and EU and implement requirements into locally applicable procedures (SOPs, Guiding Documents, Working Instructions, etc) Establish a QMS for device activities within FKSBS in accordance with applicable standards and regulations Manage GMP/MDR/GDP quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriers by planning and executing vendor audits, including monitoring of CAPA progresses till completion Negotiate, establish and maintain quality agreements Perform Gate Reviews for PPQ readiness On-site presence during critical activities (e.g. PPQ campaign, Tech Transfer, HA inspections) Define KQIs/KCIs, collect data for periodic management review to identify Risks and mitigate Ensure Inspection readiness of Medical Device Vendors and CP CMOs Manage GMP compliance during Tech Transfer of manufacturing, assembly, testing and packaging of Combination Product by authoring, reviewing, approving, as applicable, protocols, plans and reports (e.g. Validations) Identify the risks and establish appropriate mitigation plan Contribute to QM programs and GMP/MDR/GDP compliance activities as appropriate Your profile Qualification Profile: A BA/BS, MA/MS or PhD in a technical or engineering discipline or related field Minimum seven years' experience in a Quality function with increasing levels of responsibility in the biotech, life science or pharmaceutical industry Strong understanding and interpretation of EU and US medical device regulations, ISO 13485, GMP requirements for sterile manufacturing and combination products Experience with regulatory agencies such as the FDA, EMA, etc. Direct experience with GMP as well as clinical and commercial quality assurance Proven success in third-parties' quality management with clinical and commercial products Skills: Excellent communication skills in English, both written and oral Demonstrated ability to work effectively in a team-oriented environment Demonstrated skills in Leadership, Drive, Intensity, Enthusiasm Goal Orientation/Commitment to Task/Follow-up Decision Making & Problem Solving Flexibility Self-motivated Apply now  Share by email  Print this page Contact Karen Ibarra-Gonzalez Fresenius Kabi SwissBioSim GmbH Ref. number: 43163>  fresenius-kabi.com At a glance Career level: Professional Experienced Job category: Quality Management / Environment Working condition: Permanent / Full-time Business segment: Fresenius Kabi Location: Eysins / International Closing date for applications: none - we look forward to your application About Fresenius Over 300,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career - and to become part of our impressive growth story.>  career.fresenius.com >  fresenius.com One of Fresenius' strengths: our corporate culture for "entrepreneurs in an enterprise" where you can quickly take on responsibility. The benefits we offer: Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs. >  More reasons >  More benefits Fresenius Kabi SwissBioSim GmbH https://files.relaxx.center/kcenter-google-postings/kc-18740/logo_google_kabi.png 2021-06-12T14:23:35.228Z FULL_TIME YEAR null Eysins 1262

Projekt- und Produktmanagement/ Qualitätsmanagement

Technische Berufe/ Fertigung/ Produktion

Ingenieurwesen

Sonstige Branchen

Medizintechnik/ Optik

Angestellter/ Fachkraft

Vollzeit