Manager, Global Document Management

About the role

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.

Responsibilities

• Support the development, implementation, continuous improvement and documentation of Otsuka Companies’ Quality System
• Cover GxP related Functional Areas 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
• Support inspections
• Support the preparation for GxP inspections
• Support the responses to Regulatory Authorities
• 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
• Cookordinate 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
• Provide advice and act as project liaison
• Support project activities as assigned
• Support Monday.com activities, keeping the team informed about changes

Qualifications/Experience

• 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

Competencies

• 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

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage
• Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance
• Tuition reimbursement
• Student loan assistance
• A generous 401(k) match
• Flexible time off
• Paid holidays
• Paid leave programs