Functional Goal:
This position has primary responsibility for providing Quality Assurance and Quality Management Oversight to ensure that biosimilars products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices and other applicable regulations within Fresenius Kabi operational units or at the relevant C(D)MO and suppliers. They will ensure that throughout the Product Life Cycle, Quality is consistently and pro-actively represented. He/she will have hands-on experience in managing analytical method transfer and/or technology transfer activities of DS, DP and CP.
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);
* Support a GMP compliant transition of Programs from development to commercial;
* Support GMP compliance during Tech Transfer of manufacturing activities of Combination Product by:
o Reviewing, approving, approving, (authoring if needed), as applicable, protocols, plan and reports (e.g. validation);
o Identify the risks and establish appropriate mitigation plan.
* Support GMP compliance during Analytical Transfer activities;
* Collect, record and process Events, Changes, CAPAs liaising with the relevant functions of the Business Unit, Production Units (PUs) and Suppliers;
* Support Supplier & Customer qualification and maintenance activities, including external audit program;
* Collect Key Quality/Compliance Indicators for periodic review of local Quality Management System.
Other Tasks:
* Contribute to Quality Programs and overall compliance of the FKSBS´ business as appropriate;
* Support GMP/GDP/MDR quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriers by:
o Planning and executing vendor audits, including monitoring of CAPA progresses till completion;
o Negotiate, establish and maintain quality agreements;
o Perform Gate Reviews for PPQ readiness;
o On-site presence during critical activities (e.g. PPQ campaign, Tech Transfer, HA inspections);
o Define KQIs/KCIs, collect data for periodic management review to identify Risks and mitigate.
o Ensure Inspection readiness of internal Production Units and external CMOs
Qualification Profile:
* A BA/BS, MA/MS or PhD in a scientific discipline or related field;
* Minimum 4 years' experience in a Quality function with increasing levels of responsibility in the biotech, lifescience or pharma industry;
* Strong understanding and interpretation of Quality Standards (such as ISO 9001, ISO 13485), cGMP & GDP requirements for Pharmaceuticals and Combination Products, including Biologic Products;
* Experience with regulatory agencies such as Swissmedic;
* Proven success in third-parties’ quality management.
Skills:
* 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;
* Excellent planning and organization skills, detail- oriented 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.
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