Description

Otsuka-people creating new products for better health worldwide.

More than 47,000 employees worldwide in the 196 companies of the Otsuka Pharmaceutical Group are committed to this. With creativity and a spirit of research, we develop innovative products to treat diseases and maintain health, among other things. Since its foundation in Japan in 1921, Otsuka has passed through many important milestones and is now a global healthcare group operating in 28 countries with a unique corporate culture that combines Japanese and Western values. An inspiring environment for people who are open to innovation and creativity and want to make a difference together

For Otsuka Pharma GmbH in the department Global Quality we are looking for a full-time employee as soon as possible as

Senior Manager, GxP Controlled Document Management (m/f/d)

  • Management and administration of the global GxP Policies, Standard Operating Procedures (SOPs) and Working Practices (WPs)
  • Cover GxP documents related to Medical Affairs, Regulatory Affairs, IT, and others if needed
  • Independently coordinate the development and revision of these documents, following the Global Procedure for document management
  • Create project plan and maintain timelines, drive revisions to completion
  • Provide oversight and guidance for Key Stakeholders of SOPs
  • Maintain current records in the electronic Document Management System (eDMS)
  • Liaise with the Global Training Group
  • Support the management of deviations and CAPAs related to GxP Document Management
  • Participate in internal improvement projects, lead projects as assigned

  • Education in natural science or equivalent number of years’ experience
  • At least 5 years of pharmaceutical or medical device industry experience, preferably including Quality Management for GxPs
  • Expert knowledge and experience in relevant regulations and guidance documents, e.g. in the area of Clinical Development, Medical Devices, IMP management, Regulatory Affairs or Pharmacovigilance
  • Strong expertise with MS Word and MS Teams, including managing teams and channels
  • Working expertise with MS PowerPoint and Visio
  • eDMS and project management software knowledge preferred, e.g. Veeva QualityDocs, Monday.com
  • Project Management experience, ability to work with stakeholders across time zones
  • Excellent communication skills in English, written and spoken, ability to explain processes and to guide internal customers on different hierarchy levels and from different countries
  • Accustomed to working independently, with a high degree of accuracy, and the ability to be flexible and adaptive to change
  • Strong problem management skills; using analytical and creative thinking
  • Ability to come to the office 2 days a week during the onboarding, and once per month after that
  • Japanese language skills would be a bonus

Otsuka Pharma GmbH combines the advantages of a large corporation with those of a small company. We benefit from financial security and infrastructure as well as direct decision-making channels and flat hierarchies. We all know each other personally, work together and support each other – we are a team!

In addition to traditional benefits such as a company pension scheme, health allowances and a travel allowance, we also offer you a childcare allowance, the option of additional days off and individual training opportunities.