Global Data Management & Process Quality Director

Merck; Rahway (NJ); Hybrid; USD 173,000 - 273,000; Full time

Job summary

Merck is seeking a Senior Director and Head of GDMS Process and Quality Management to develop and oversee the GDMS compliance framework, training, and quality activities. The role requires leadership of process owners, alignment with clinical programs, and ensuring documentation and training meet regulatory standards.

The incumbent will drive inspection readiness, CAPA management, and continuous improvement while reporting to the Head of Global Data Management and Standards.

Qualifications

• Bachelor’s degree in life sciences, medicine, pharmacy, nursing, health informatics, or other healthcare-related field.
• Experience with clinical data management processes across full lifecycle and quality management.
• Strong knowledge of ICH-GCP and regulatory requirements.
• Leadership and people management in a global matrix organization.
• Familiarity with RBQM, clinical trial technologies, and inspection readiness.

Responsibilities

• Establishes GDMS operating model, governance cadence, priorities, decision rights, and escalation pathways.
• Acts as Process Owner for all GDMS processes and leads a network of SPOs.
• Partners to align training strategy with process requirements and role expectations.
• Ensures process documentation and training are high quality and compliant with regulations.
• Leads audits, inspections, and CAPA management for GDMS activities.
• Serves as COE for business process management and translates learnings into improvements.
• Develops metrics to monitor effectiveness, gaps, and continuous improvement.
• Engages with stakeholders and regulatory inspectors to maintain quality and compliance.
• Contributes to organizational strategy and transformation as a GDMS Leadership team member.

Skills

Adaptability

Audit Inspections

Clinical Data Management

Ethical Standards

GCDMP

GCP

Lean Continuous Improvement

People Leadership

Strategic Thinking

Team Leadership

Education

Bachelor's degree in life sciences or healthcare field

ACRP/CCDM/CMQ/OE/CQA certifications

Job description

Merck is seeking a Senior Director and Head of GDMS Process and Quality Management to develop and oversee the GDMS compliance framework, training, and quality activities. The role requires leadership of process owners, alignment with clinical programs, and ensuring documentation and training meet regulatory standards.

The incumbent will drive inspection readiness, CAPA management, and continuous improvement while reporting to the Head of Global Data Management and Standards.