/ 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 / Responsible Person (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.
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.
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
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
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
Willingness to travel
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Fresenius Kabi SwissBioSim GmbH
Ref. number: 52321
At a glance
Quality Management / Environment
Permanent / Full-time
Eysins / International
Closing date for applications:
none – we look forward to your application
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.
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
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