HomeJobsucheSenior Manager Quality …
EysinsUnbefristetVollzeit

Senior Manager Quality Management / Responsible Person (m/f/d)

Job merken

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

The Business Unit Generics & IV Fluids, specializes in a wide array of therapeutic categories of injectable medicines: Critical Care, Anti-Infectives, Analgesia & Anaesthesia, Oncology and other Generic drugs, as well as Intravenous Solutions for critically and chronically ill patients.

This Business Unit has centralized in the Geneva region the global team to support the In Licensing activities like, amongst others: Alliance Management, Business Development, and Trading of finished products. The concerned products can be developed and manufactured by business partners. In this context, we are looking for candidates for the position in subject.

Fresenius Kabi SwissBiosim has also been certified as an Equal Pay Employer.

This position has primary responsibility to ensure that the generic Medicinal Products traded by FKSBS are in continuous compliance with applicable law and regulations (GxP, ICH, ISO especially ISO9001)

This position has the responsibilities of the “Responsible Person” for Generics.

Your assignments

  • As registered Responsible Person in the Swissmedic Establishment Licenses ensure that the company’s activities for generics commercial medicinal products comply with the applicable regulations as laid down in the Swiss Therapeutic Act (TPA), the Medicinal Products Licensing Ordinance and applicable GDP guidelines as follows:
  • Monitor and ensure compliance with applicable GDP guidelines including trainings of FK-SBS personnel as required
  • Review and approve change controls, deviations, complaints, CAPA, organization charts, Job Descriptions as required
  • Manage Supplier and Customer qualification & approval, including establishment of Quality/Technical Agreements
  • Lead internal and external audits as a Qualified Auditor of Fresenius Kabi
  • Contribute to inspections management, product recalls, quality management review, notification to Swissmedic
  • Responsible to give instructions to the management on quality topics that relate to generics commercial products.
  •  Manage the applicable GDP quality tasks and support the GMP activities for the trading of Generic Medicinal Products
  • Oversee the collection and processing of Events, Changes, CAPAs liaising with the relevant functions of the respective Business Unit, other Fresenius Kabi entities and Suppliers
  • Identify applicable regulations, procedures and respective training needs for the BU Generics team at FKSBS
  • Lead continuous improvement of quality processes associated to commercial generics, such as, but not limited to, inspection readiness, internal & external audits, supplier management, documentation, changes / events, CAPAs, management reviews, recalls.
  • Support Suppliers’ Due Diligence activities
  • Support the Suppliers quality management system, including external audit program
  • Provide quality support to new launches as applicable
  • Collect Key Quality/Compliance Indicators for periodic review of local Quality management system
  • Manage internal audits (self-inspections) program by planning, executing, reporting and monitoring upon close-out
  • Monitor Quality KPIs for trends and notify management of events requiring and immediate action.
  • Provide relevant input for BU Generics & IV Fluids for Quality Management Review
  • Act as deputy Responsible Person (FvP) for the RP responsible for Biosimilars and manage the Quality Systems related to the Swissmedic Establishment Licenses for Import, Export, Wholesale and Foreign Trade of Medicinal Products, ensuring continuous compliance with the Swiss Therapeutic Products Act (TPA), the EU GDP and any other applicable regulations
  • Contribute to Quality Programs, GxP and ISO 9001:2015 compliance activities as appropriate

Your profile

Qualification profile:

  • A BA/BS, MA/MS or PhD in a scientific discipline or related field
  • Minimum 5 years’ experience in a Quality function with increasing levels of responsibility in pharmaceutical industry
  • Strong understanding and interpretation of GMPs and GDP and best quality practices with regards to manufacturing & distribution processes
  • Experience with regulatory agencies such as the Swissmedic, EMA, FDA etc.
  • Prior experience as Responsible Person & interactions with Swissmedic & ISOPTh

Skills:

  • Excellent communication skills in English & French, both written and oral, knowledge of German is an asset
  • 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

Other:

  • Willingness to travel

Auf einen Blick

Standort:

InternationalEysins

Karrierelevel:

Berufserfahrene

Einsatzbereich:

Qualitätsmanagement / Umwelt

Arbeitsverhältnis:

UnbefristetVollzeit

Unternehmen:

Fresenius Kabi

Bewerbungsfrist:

none - we look forward to your application

Referenznummer:

52321

Veröffentlicht am:

23.08.2022

Solange die Stellenanzeige online ist, können Sie sich schnell und einfach bewerben.

Ihr Kontakt

Amélie Curchod
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Diesen Job empfehlen

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

Wenn es nicht nur ein Job ist, sondern Ihre Berufung. Wenn Sie jeden Tag einen positiven Einfluss auf das Leben von Menschen haben. Wenn Sie sich nicht vorstellen können, etwas anderes zu tun. Dann ist es Fresenius.