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.

  • 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

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
  • Karrierelevel:
  • Berufserfahrene
  • Einsatzbereich:
  • Qualitätsmanagement / Umwelt
  • Arbeitsverhältnis:
  • Unbefristet / Vollzeit
  • Unternehmensbereich:
  • Fresenius Kabi
  • Standort:
  • International / Eysins
  • Bewerbungsfrist:
  • none - we look forward to your application
Karen Ibarra-Gonzalez
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Ref. number: 43163

Offen für Individualität und Vielfalt

Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, Alter, Herkunft, Nationalität, Religion, Behinderung, sexueller Identität und Orientierung oder sonstigen Merkmalen.

Sämtliche Personenbezeichnungen in dieser Stellenausschreibung gelten für alle Geschlechter gleichermaßen (männlich, weiblich, divers).

Karriere mit Sinn

Mehr als 300.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

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

Ihr Kontakt

Karen Ibarra-Gonzalez
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Ref. number: 43163

Karrierelevel
Berufserfahrene
Einsatzbereich
Qualitätsmanagement / Umwelt
Arbeitsverhältnis
Unbefristet / Vollzeit
Unternehmensbereich
Fresenius Kabi
Standort
International / Eysins
Bewerbungsfrist
none - we look forward to your application

Offen für Individualität und Vielfalt

Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, Alter, Herkunft, Nationalität, Religion, Behinderung, sexueller Identität und Orientierung oder sonstigen Merkmalen.

Sämtliche Personenbezeichnungen in dieser Stellenausschreibung gelten für alle Geschlechter gleichermaßen (männlich, weiblich, divers).

Karriere mit Sinn

Mehr als 300.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

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