Description:

Scope of Work – for recruiting purposes

Good Vigilance Practice (GVP) Auditor

The GPV Auditor will lead and perform audits with a focus on Pharmacovigilance activities. Additional tasks are required to support the continuous improvement of the Otsuka Quality System, inspection management, regulatory intelligence activities, SOP and WP management, validation activities, and project liaison activities.

Significant travel in excess of 50% is expected

Pharmacovigilance Audits

• Implement & maintain the global pharmacovigilance risk-based strategy for audit and risk assessment activities
• Lead, plan, conduct, and support internal and external GxP audits in line with the global audit plan, Otsuka’s business model and applicable procedures
• Follow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditees
• Maintain a tracking tool for audits, findings and corrective and preventive actions
• Provide business support as Global Quality representative for routine software/infrastructure lifecycle activities (systems introduction/maintenance/retirement)

Otsuka Companies’ Quality System

• Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and ‘lessons learned from audit/ inspection’
• Cover GxP related Functional Areas, specifically related to GCP, GVP, GMP and CSV.
• Collaborate with the respective Functional Area Heads/representatives and Global and Regional Quality Leads and functions.
• Ensure the establishment and maintenance of the required Quality Documentation
• Ensure SOPs/ WPs are compliant with applicable requirements and regulations and mirror the actual Otsuka company processes
• Identify process gaps and deficiencies in the Quality System, liaise and collaborate continuously with other Functional Areas and other partners for resolution
• Manage planned and unplanned deviations reported by the Functional Areas and support them by resolving the deviations.
• Develop and support global compliance training procedures in collaboration with other Otsuka companies and provide training in the area of expertise as assigned.

Inspections

• Support the preparation for GxP inspections
• Support the responses to Regulatory Authorities and provide input to the corrective and preventive actions
• Follow-up on the development, implementation and completion of corrective and preventive actions with the inspected Functional Areas
• Maintain a tracking tool for inspections, findings and corrective and preventive actions

Regulatory Intelligence

• Maintain an overview over the relevant regulatory requirements and state-of-the-art knowledge of development in the professional regulatory environment to be able to provide guidance for timely adaptation of Otsuka’s procedures.
• Evaluate impact of regulatory changes for the Otsuka Quality System
• Ensure information sharing and action taking
• Enable Otsuka to maintain the Quality System in an compliant state with a changing regulatory environment

Provide advice and act as project liaison

• Provide sound advice and interpretations related to current GxP guidelines and regulations to Senior Management and Otsuka employees
• Be accountable for quality-related input in decision making processes with relevance for GxP compliance
• Act as quality liaison for assigned projects

Requirements:

• Degree in natural science or equivalent number of years’ experience
• Experience in Pharmacovigilance auditing (Qualification as an auditor preferred)
• Several years of clinical/industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Management for Pharmacovigilance or Clinical Development or Computer System Validation
• Expert 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
• Exposure to inspections

COMPETENCIES

• Understanding of pharmacovigilance requirements
• Understanding of audits and CAPA management
• Understanding of change management processes
• Well versed with MS Office (advance users in Excel & PowerPoint preferred)
• Excellent communication skills (written and oral) in English
• Problem solving and resolution skills
• Analytical and creative thinking

General Comment:

NOTES FROM KEREN:

• ROS: Mijal Chavda (Director, Global Quality Management)
• Timeline to Hire: ASAP
• Duration: 1 year
• Location: Princeton *Ideally based in Princeton onsite (2 to 3 days per week) but will consider strong remote candidates
• Reason for Opening: New, workload increase