Senior Director, Head of Global Data Management and Standards (GDMS) Process & Quality Management - Hybrid
$173.2k - $272.6kMerck
Senior Director leading Global Data Management and Standards (GDMS) Process and Quality Management at Merck. Responsible for developing and maintaining GDMS processes, governance frameworks, training compliance, and quality management activities across clinical operations. Reports to Head of Global Data Management and Standards.
Responsibilities
- Establish and maintain GDMS operating model, governance structure, priorities, and escalation pathways
- Serve as Process Owner for all GDMS processes and direct network of Sub-Process Owners
- Ensure GDMS process documentation and training are complete, aligned, and compliant with regulations
- Lead GDMS responses to audits, inspections, and manage CAPA activities
- Develop performance metrics and drive continuous improvement through learnings from inspections and quality issues
Requirements
- Bachelor's degree in life sciences, medicine, pharmacy, nursing, health informatics, or related healthcare field
- 10+ years clinical data management experience in pharmaceutical or biotech industry
- 5+ years directing or managing process and quality management operations
- 5+ years personnel management experience, including direct line management in matrixed global organizations
- Experience managing clinical data management processes across full lifecycle and leading audit/inspection activities
- Knowledge of clinical data standards, ICH-GCP, and regulatory requirements
- Experience with data management and clinical trial technologies
Vacancy posted 3 days ago
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