DESCRIPTION OF ROLE

The main task is to manage and perform audits with focus on Pharmacovigilance audits. Additional tasks are to support the continuous improvement of the Quality System, the inspection management, the regulatory intelligence activities, the SOP and WP management, the validation activities and the project liaison activities.

KEY RESPONSIBILITIES & DECISIONS

1. Pharmacovigilance Audits
   • Implement & maintain the global pharmacovigilance risk-based strategy for audit and risk assessment activities
   • Manage audits and contract auditors in line with the global audit plan, company business model and applicable procedures
   • Plan, supervise, conduct, and support internal and external GxP audits
   • 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
   • Select and manage qualified service providers for Global Quality, e.g., contract auditors
   • Provide business support as Global Quality for routine software/infrastructure lifecycle activities (systems introduction/maintenance/retirement)

2. 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 thus related to GCP, GVP, GMP and CSV.
   • Collaborate with the respective Functional Area Heads/representatives
   • Collaborate with the respective Global and Regional Quality Leads and functions
   • Foster a continuous improvement mentality within the company
   • Ensure the establishment and maintenance of the required Quality Documentation
   • Ensure SOPs/ WPs are compliant with applicable requirements and regulations
   • Ensure SOPs/ WPs mirror the actual company 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 client companies and provide training in the area of expertise as assigned.

3. Inspections
   • Support the preparation for GxP inspections
   • Support the responses to Regulatory Authorities
   • Supervise 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

4. 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  company procedures.
   • Evaluate impact of regulatory changes for the company Quality System
   • Ensure information sharing and action taking
   • Enable the company to maintain the Quality System in a compliant state with a changing regulatory environment

5. 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

JOB SCOPE (key facts)

• Located in UK/Europe
• The employee will report to Director of Global Quality Operations

QUALIFICATIONS/ EXPERIENCE

• 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
• 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