/ 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 Operations Development Programs & LCM, 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 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.
Fresenius Kabi SwissBiosim has also been certified as an Equal Pay Employer.
Maintain an up-to-date knowledge of cGxP regulation and applicable standards (especially in the US and EU) and implement requirements into locally applicable procedures (SOPs, Guiding Documents, Working Instructions, etc.)
Manage a GMP compliant transition of Programs from development to commercial
Manage GMP compliance during Tech Transfer of manufacturing activities of Combination Product by
authoring, reviewing, approving, as applicable, protocols, plans and reports (e. g. Validations)
Identify the risks and establish appropriate mitigation plan
Manage GMP compliance during Analytical Transfer activities
Manage internal and external Change Controls, Deviations, Events, CAPAs, etc., related to Drug Substance, Drug Product and Combination Products
Contribute to QM programs and GMP / GDP / MDR compliance activities as appropriate
Manage GMP / GDP / MDR quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriers by
P lanning 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 internal Production Units and external CMOs
Oversight of Biosimilar´s Foreign Trade business in role as (deputy) Responsible Person
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, lifescience or pharmaceutical industry
Strong understanding and interpretation of Quality Standards (such as ISO 9001, ISO 13485, ICH Q8, ICH Q9 & ICH Q10), cGMP requirements for Pharmaceuticals and Combination Products, including Biologic Products
Strong understanding of GMPs and best quality practices with regards to biotech manufacturing processes
Experience with regulatory agencies such as the FDA, EMA, etc.
Proven success in third-parties‘ quality management
Excellent communication skills in English, both written and oral, French and German as 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
Share by email
Print this page
Fresenius Kabi SwissBioSim GmbH
Ref. number: 53981
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
> More benefits
Fresenius Kabi SwissBioSim GmbH https://files.relaxx.center/kcenter-google-postings/kc-18740/logo_google_kabi.png