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Manager, QA Documentation

Inseriert am: 28.04.2021

Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb und machen Sie einen Unterschied. This position is within the Internal Manufacturing Quality Operations organization of Boudry site. As part of the QA Documentation team, the Manager, QA Documentation is responsible to support the Quality Documentation management system (DMS) and GMP/GDP Learning Management system (LMS), its maintenance and continuous improvement. In addition, the position holder supports the GMP/GDP Training management system, including the maintenance of the LMS. DUTIES AND RESPONSIBILITIES 1) As part of the QA Documentation team, the Manager, QA Documentation acts as Administrator and Super-User of the electronic Documentation Management System and has the following responsibilities related to: Documentation management Ensure Quality Documentation complies with established electronic Documentation System standards & document management policies (act as document reviewer/approver) Provide timely and efficient support to systems users in handling document workflows and managing document change requests Monitor progress of documents through the electronic workflows Proactively manage the Periodic Review Process of quality documents Provide expertise to site authors on document technical writing and effective document design Assist with the documentation and training management systems document authoring Documentation and data retention: Ensure documentation/data are physically and electronically archived and retained in compliance with Regulations, policies and Data Integrity requirements. Initiate the annual documentation and data destruction process as per applicable standards. 2. The Manager, QA Documentation acts as Administrator and Super-User of the electronic Learning Management System and has the following responsibilities related to training management: Responsible for the creation and assignment of GMP/GDP training in electronic Learning Management system (ComplianceWire), as well as curriculum and user groups periodic review Create, update personnel training profiles according to the training management and user requests Support training material authors in creating effective training content design (eg, E-learning tools, animated training, video) Deliver instructor-led training associated with our "Train the Trainer program" and New Employee Orientation training Train end-users on the Documentation and Training processes and associated IT systems SKILLS/KNOWLEDGE REQUIRED Economic or administrative degree or equivalent training/education Must have experience with cGMP manufacturing, Quality, and Compliance (minimum of 8 years), specifically in handling GMP/GDP Documentation & Training Good understanding of records management and retention policies Good understanding of Data Privacy regulations and its compliance Expertise in document technical writing/document authorship, Experience in effective training content design and development utilizing different tools (incl. e-learning, video…) Comfortable providing instructor-led training (New Employees Orientation training/system access training…) and guidance to system users as needed. Good communication and ability to work effectively in multicultural environment and multisite team. Must be well organized and self-directed Proactive and continuous improvement oriented Fluent in French and English Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor. Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen.


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