Zug, Zug, Switzerland
A highly skilled and results-driven External Supply Operations and Quality Management Professional with scientific background, I bring over a decade of experience in the pharmaceutical and biotechnology industries. With expertise in CMO relationship management, supply chain operations, and quality assurance, I have successfully led drug product and packaging supply strategies, ensuring seamless product supply from clinical to commercial launches across global markets, including Europe, Middle East, Latin America, and APAC. I am passionate about ensuring efficient, high-quality, and compliant pharmaceutical supply chains that support global patient needs.
Provides strategic technical leadership for commercial finished goods setup and production across Europe, Japan, and the MENA region. Leads the selection and management of packaging contract organizations (COs), including negotiation of commercial terms and pricing. Oversees the review and approval of technical, operational, and quality documentation, while contributing strategic guidance to packaging development to ensure robust product supply continuity. Responsible for managing third-party logistics (3PL) operations in Japan and coordinating launch activities to support successful market introduction.
· Managed contract manufacturing organisations (CMOs) for drug product and packaging, ensure supply continuity and risk mitigation. · Define product supply strategies with external partners, overseeing supply risk assessment, order management and lifecycle planning. · Account budget planning, support latest estimation for finance department. · Managed direct and indirect reports in a leadership capacity. · Played a key role in Oracle to SAP ERP system integration project and SAP S/4 HANA implementation. · Coordinating new product launches between internal stakeholders and external suppliers for launch in various countries including middle east, latin and APEC.
· Managed contract manufacturing organisations (CMOs) for drug product and packaging, ensure supply continuity and risk mitigation. · Define product supply strategies with external partners, overseeing supply risk assessment, order management and lifecycle planning. · Account budget planning, support latest estimation for finance department. · Managed direct and indirect reports in a leadership capacity. · Played a key role in Oracle to SAP ERP system integration project and SAP S/4 HANA implementation. · Coordinating new product launches between internal stakeholders and external suppliers for launch in various countries including middle east, latin and APEC.
· Managing CMO relationship for primary/secondary packaging CMO · Participation in RFP, supplier selection and contract negotiations. · Served as an SME for solid oral dose blistering/cartoning processes. · Coordinating product launch in EU, GB and Switzerland
· Served as QA relationship manager for CMOs handling small molecules, biologics, pre-filled syringes (PFS), pen assembly and packaging. · Negotiated and managed technical quality agreements with external suppliers. · Extensive experience in biologic combination products including pen assembly, pre-filled syringe and have very good knowledge regarding design control as well as regulations associated with medical devices (ISO 13485, FDA 21CFR). · Strong knowledge of QMS, cGMP regulations in US, EU, Japan and China. · I was the project manager for an aseptic filling PPQ project at CMO (short term assignment).
· I played a key role in implementing the importation process for Biosimilar Drug substance and Drug products manufactured outside the EU. · I lead various continuous improvement project, cost reduction project and process optimisation projects within the quality team.
· I participated in an AQL gap analysis project, gaining deep knowledge in small molecule manufacturing and processes, including the packaging process. I delivered a comprehensive report including all the data collected from CMOs. · I successfully delivered a risk-based rationale to justify trending minor deviation at CMOs.
Translator and proofreader Translating dental documents and clinical research documents from Japanese into Chinese.
Neuroscience focusing on hippocampus, species comparison and Alzheimer's related molecules. Statistics: regression, ANOVA (in R), principal component analysis, correspondent analysis. Scientific paper writing