Regional Process Lead

vor 2 Wochen

Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

Job DescriptionWith over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.We are seeking a highly qualified candidate to fill the position:Regional Process Lead (m/f/x) eQMSRegional accountability for overseeing and enhancing eQMS system processes to ensure operational efficiency and transparencyDrive standardization of the assigned system processes – both in the area of GMP and GDPCollaborate closely with the regional Business Process OwnerContinuously monitor process performance and derive measures for process improvement in close cooperation with various global and regional stakeholdersSupport implementation of best practice standards and ensure compliance with quality and regulatory requirements in your own area of responsibilityCollaborate closely with global Process Leads and actively contribute to shaping global eQMS systemEnsure continuous operational readiness of system processes by maintaining up-to-date documentation, including procedures, templates, and work instructions within DSEDevelop and deliver training for employees for the assigned system processesCompleted studies in natural sciences / pharmaceutical sciences or a comparable qualification5+ years of relevant professional experience in a GMP/GDP-regulated environmentExperience with electronic QM systems (e.g., TrackWise Digital, Veeva Quality Vault, etc.)Experience with computer system validation is a plusExcellent communication skills and experience in stakeholder managementStrong analytical skills and attention to detail, with the ability to communicate complex matters/concepts to various stakeholdersVery good knowledge of relevant regulations from various authorities (e.g., EMA, SwissMedic, MHRA, Health Canada, etc.)Excellent German and English skills, both written and spokenExcellent BenefitsWork-Life BalanceGrowth and DevelopmentHealth and Wellbeing Support

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    vor 1 Tag

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

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  • Regional Process Lead

    vor 2 Wochen

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    Job DescriptionWith over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from...

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