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.

KEY RESPONSIBILITIES

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:

1. 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
• Executes 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 Monday.com activities, keeping the team informed about changes

JOB SCOPE (key facts & figures)

• 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

QUALIFICATIONS/ EXPERIENCE REQUIRED
• 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 REQUIRED
• 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

Competencies
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 $107,718.00 - Maximum $161,000.00, 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 role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline: This will be posted for a minimum of 5 business days.

Company 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, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.