Manager, Global Document Management

The main task is to support the management of global, regional and local procedural and governance documents and related activities.

Additional tasks are to support the continuous improvement of the Otsuka Quality System, the inspection management, the regulatory intelligence activities, the validation activities and the project liaison activities, as per request.

This position is a member of Global Quality in the Global GxP Document Management (GDM) function. Primary responsibilities, in close collaboration with the GSOP Lead GxP Document Management, are:

• Cover GxP related
  
  Functional Area
  
  s as assigned
• Collaborate with the respective
  
  Functional Area
  
  Heads
• Collaborate with the respective Global and Regional Quality Leads and functions
• Foster a continuous improvement mentality within Otsuka
• Executes the establishment and maintenance of the required Quality Documentation and ensure appropriate quality standards are adhered to in the management of this documentation

• Support the preparation for GxP inspections
• Support the responses to Regulatory Authorities

• Support with the development and implementation Otsuka’s global Quality Management System (e.g., policies, global SOPs, WPs) to ensure compliance with regulatory requirements and maintain global harmonization
• Provide oversight and recommendations and guidance for Key Stakeholders, in determining adequacy of existing policies and global SOPs and requesting revision where appropriate to maintain a compliant Quality Management System
• Coordinate and support the development and revision of global SOPs and global working practices including attachments and templates
• Inform Global Training about document status to have training set-up completed before sending the document for approval.

• Support project activities as assigned.
• Support  activities, keeping the team informed about changes

• Located in United States of America
• The employee will report to the Senior Manager, Global Document Management for the purposes of overall functional guidance and day to day Line Management

• Degree in natural science or equivalent number of years’ experience
• 4+ years of clinical/industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Management for Pharmacovigilance or Clinical Development or Computer System Validation
• Advanced knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance
• Experience in Monitoring, Quality Assurance and/or Good Clinical Practices

• Understanding of change management processes
• Well versed with MS Office
• Very good communication skills (written and oral) in English
• Problem solving and resolution skills
• Analytical and creative thinking

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the…