Senior Director - Head of Inspection & TMF

Senior Director - Head of Inspection & TMF

Geneva, Switzerland | Hybrid (3 Days in office)

About the Role:

We are partnering with a global pharmaceutical organization seeking a Senior Director to lead its Inspection & TMF Centre of Excellence.

This newly created position offers the opportunity to lead a global team, shape inspection strategy and drive clinical quality excellence across the organization.

Your Responsibilities

• Lead a global team across Inspection Excellence, TMF and Clinical Quality.
• Drive inspection readiness across FDA, EMA, MHRA and PMDA.
• Oversee mock inspections, back-room activities and regulatory responses.
• Lead global TMF strategy, eTMF oversight and quality standards.
• Drive TMF innovation, including the evaluation of AI capabilities.
• Oversee audits, CAPAs, quality metrics and continuous improvement.

Your Profile

• Senior leadership experience within Clinical Quality Management.
• Strong hands-on Health Authority inspection experience.
• Experience with inspection readiness and back-room activities.
• Solid TMF and eTMF expertise within clinical trials.
• Strong GCP and global regulatory knowledge.
• Proven experience leading international teams.

The Opportunity

• Lead a newly established global function.
• Shape global Inspection and TMF strategy.
• Work alongside senior international stakeholders.
• Drive innovation and the future of Clinical Quality.