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