Section Director, Inspection Excellence

Role Summary

Section Director, Inspection Excellence is a leadership role within Global Patient Safety, responsible for leading the Inspection Excellence team and ensuring inspection readiness across Patient Safety operations. The role coordinates regulatory inspections and audits, drives quality improvement initiatives, and collaborates with the QPPV & PV Excellence leadership to execute the Inspection Excellence strategy.

Responsibilities

• Inspection Readiness and Coordination
  • Maintain continuous inspection readiness across all Patient Safety functions
  • Lead coordination of GVP, GCP, and GMP inspections and audits
  • Ensure appropriate pharmacovigilance input throughout inspection processes
  • Coach team members to develop expertise in inspection coordination
• Quality Management and Compliance
  • Develop high-quality pharmacovigilance quality issues and risk assessments with corresponding CAPA
  • Utilize root cause analysis methodologies to support quality improvement initiatives
  • Manage timely delivery of effective pharmacovigilance CAPA and risk mitigation strategies
  • Report pharmacovigilance quality status to business leadership and senior management
• Team Leadership and Management
  • Provide strategic leadership and direction for the Inspection Excellence team
  • Manage team performance and professional development to achieve strategic goals
  • Collaborate with the Inspection Excellence Leadership Team to define organizational strategies and objectives
  • Be a member of QPPV & PVE LT contributing to overall QPPV & PVE team strategy and goals
• Strategic Operations and Innovation
  • Identify opportunities to implement AI and automation technologies to enhance efficiency and quality
  • Establish systematic processes for gathering, consolidating, and communicating regulatory authority and industry intelligence
  • Drive proactive continuous improvement initiatives to ensure regulatory compliance and operational excellence
  • Manage projects according to established targets while providing expert pharmacovigilance guidance
• Stakeholder Engagement and Collaboration
  • Maintain effective relationships with QA functions within R&D, EU Qualified Person for Pharmacovigilance, Global Markets, Clinical functions, and Operations
  • Engage and influence internal and external stakeholders to advance strategic objectives
  • Ensure customer requirements are understood, evaluated, prioritized, and addressed appropriately
  • Participate in governance of alliance and partnership models

Qualifications

• University degree in relevant scientific discipline
• Demonstrated experience in pharmacovigilance and regulatory compliance within pharmaceutical, clinical, regulatory, or pharmacovigilance environments
• Comprehensive knowledge of global pharmacovigilance requirements
• Experience with regulatory inspection activities
• Proven ability to manage multiple stakeholders effectively
• Experience applying strategic direction to teams and projects within cross-functional or global environments
• Extensive project management experience with team leadership responsibilities
• Demonstrated ability to utilise AI and automation technologies to enhance efficiency and quality
• Regional or global line management experience
• Excellent written and verbal communication and presentation skills
• Strong attention to detail, time management, and organizational abilities