Senior Manager Quality Operations - Development Programs & LCM (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.
- 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
- Planning 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
- 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,
- 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