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

Fresenius Kabi ist ein weltweit tätiges Gesundheitsunternehmen, das Medikamente und Medizinprodukte zur Infusion, Transfusion und klinischen Ernährung anbietet. Unsere Produkte und Dienstleistungen werden in der Therapie und Versorgung von kritisch und chronisch kranken Patienten eingesetzt.

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