Senior Manager Quality Operations & GDP / Deputy 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.

Main Tasks

• 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 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
• Act as deputy Responsible Person, Manage the GDP related quality tasks and support the GMP activities for commercial medicinal product traded by FKSBS
• Manage Events, Changes, CAPAs liaising with the relevant functions of the Business Unit, Production Units (PUs) and Suppliers
• Lead continuous improvement of quality processes associated to commercial medicinal products, such as, but not limited to, inspection readiness, internal & external audits, supplier management, documentation, changes / events, CAPAs, management reviews, recalls.
• Collect Key Quality/Compliance Indicators for periodic review of local Quality Management System
• Monitor Quality Systems for trends and notify management of events requiring and immediate action

Other Tasks:

• Contribute to internal audits & self inspections

• Support GMP/GDP/MDR 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
  • Define KQIs/KCIs, collect data for periodic management review to identify Risks and mitigate
  • Support Inspection readiness of internal Production Units and external CMOs

• Provide quality support to programs ensuring smooth transition from development to commercial

• Support Tech Transfer and Analytical Method Transfer and provide Quality Oversight for GMP compliant execution

Your profile

Qualification Profile:

• A BA/BS, MA/MS or PhD in a technical or engineering discipline or related field
• Minimum 4 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 & GDP 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

Job Specific Competencies & Skills:

• Excellent communication skills in English, both written and oral, French and German as an asset
• Demonstrated ability to work effectively in a team
• Excellent planning and organization skills, detailoriented working style
• Flexibility to switch between projects
• Demonstrated skills in Leadership, Drive, Intensity, Enthusiasm
• Goal Orientation/Commitment to Task/Follow-up
• Decision Making & Problem Solving
• Experienced in Office 365 applications
• Self-motivated