Manager, Global Document Management

POSITION SUMMARY

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.

1. Support the development, implementation, continuous improvement and documentation of Otsuka Companies’ Quality System

• 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
• Execute the establishment and maintenance of the required Quality Documentation and ensure appropriate quality standards are adhered to in the management of this documentation

2. Support inspections

• Support the preparation for GxP inspections
• Support the responses to regulatory authorities

3. Support the management of the global, regional and local Standard Operating Procedures (SOPs) and Working Practices (WPs)

• 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

4. Provide advice and act as project liaison

• 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 best results for Otsuka.

Respectful Collaboration

Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development

Play an active role in professional development as a business imperative.

Minimum $ – Maximum $, plus incentive opportunity:
The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in…