PBeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. /ppbGeneral Description: /b /ppThe Manager, Distribution Regional Quality, Europe Quality is responsible for overseeing Good Manufacturing Practices (GMP) as well as Good Distribution Practice (GDP) operations related to the commercial products including trading in foreign countries. This position ensures compliance with EU GMP and GDP regulations on transportation, wholesale and distribution. The role ensures adherence to EU regulations, as well as BeOne's internal quality processes and procedures. /ppBeOne operates several affiliates in Europe and holds different GxP licenses in these affiliates. The job incumbent will execute the assigned activities on behalf of the below listed affiliates based on the license utilized. /ppAffiliates in scope: BeOne Medicines I GmbH, BeOne Medicines I GmbH, Dutch Branch, BeOne Medicines France Sarl, BeOne Medicines UK, Ltd and BeOne Medicines Germany GmbH /ppbr/For activities performed for Switzerland under BeOne Medicines I GmbH the allowed delegations per VV-QDOC-10970 CH – Deputization and Delegation of RP Tasks within BeiGene Switzerland GmbH need to be considered. /ppbEssential Functions of the job: /b /pliTrade authorization of finished products manufactured bybr/- contract manufacturers on behalf of BeOnebr/- cooperation partners of BeOnebr/- BeOne /liliBatch Review and EU QP batch certification preparation: Batch review and release preparation for commercial APIs, primary packed products and finished products manufactured by BeOne or contract manufacturers on behalf of BeOne. /liliPerform customer and wholesaler approval /liliDeviation (incl. Temperature Excursion), CAPA and Change Control Management /liliComplaint Management (distribution complaints and market complaints) /liliPrepare, manage and maintain documentation and reports required to support and improve the execution of Regional Quality activities /liliConduct GDP releases post QP batch certification /liliEnsure Inspection readiness within area of responsibility /liliSupport Health Authority Inspections and Audits as needed. /liliSupport launch of new products in a country /liliQuality representative in SAP Project for local affiliate /liliSupport and work with in-country wholesalers and distributors/3PLs /liliSupport Quality Oversight of GDP operations and compliance /liliSupport the implementation of Quality requirements within the Distribution scope /liliSupport the customer product returns process and evaluation of the product for use /liliSupport the establishment/update of Quality Agreements with local 3PLs / distributors / wholesalers /liliAssist with preparation and provision of Key Performance Indicator metrics /liliThis is a hands-on position /lipbEducation Required: /b /pliMin 5+ years of relevant experience in Distribution Quality in pharmaceutical industry with a Bachelors degree. /liliSolid foundation in QA and understanding of product distribution quality requirements. /lipbComputer Skills: /b /pliPC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint), Veeva, SAP /liliAbility to work on a computer for extended periods of time /lipbCore Knowledge and Skill Requirements /bb: /b /pliEU GMP experience /liliEU GDP experience /liliFluent in English /liliFluent in German is a plus /lipbOther Qualifications: /b /pliVery good interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail. /lipbTravel: /b /pliMax 10 % /lipSalary Range Switzerland: 109,500.00 CHF - 136,900.00 CHF /ppGlobal Competencies /ppWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. /pliFosters Teamwork /liliProvides and Solicits Honest and Actionable Feedback /liliSelf-Awareness /liliActs Inclusively /liliDemonstrates Initiative /liliEntrepreneurial Mindset /liliContinuous Learning /liliEmbraces Change /liliResults-Oriented /liliAnalytical Thinking/Data Analysis /liliFinancial Excellence /liliCommunicates with Clarity /li