Senior Director, Head of Global Data Management & Quality Management

About the role

The Senior Director and Head of GDMS Process & Quality Management leads the development, implementation, and oversight of the global data management standards, processes, and quality framework. Reporting to the Head of Global Data Management and Standards, this role sets vision and ensures timely, high‑quality delivery of services.

Key responsibilities

• Establish and maintain the GDMS Process & Quality Management operating model, governance, priorities, and escalation pathways.
• Serve as Process Owner for all GDMS processes, directing Sub‑Process Owners and ensuring alignment across business functions.
• Partner with Business Operations to align functional training strategy with process requirements and regulatory expectations.
• Oversee documentation, training, and inspection readiness, managing audit and CAPA activities.
• Develop performance metrics, monitor trends, and drive continuous improvement.

Required profile

• 10+ years in clinical data management within pharma/biotech.
• 5+ years leading process and quality management operations.
• Proven experience managing global, matrixed teams and budgets.
• Strong knowledge of ICH‑GCP, regulatory requirements (FDA, EMA, etc.) and risk‑based clinical data management.

Required skills

• Clinical Data Management
• Audit inspections
• Good Clinical Practice (GCP)
• Good Clinical Data Management Practice (GCDMP)
• Lean Six Sigma (black/green belt)
• Data Quality Management
• Process Management
• Quality Management
• Vendor Quality Management