Global Data Management & Quality Process Leader (Hybrid)

Regulatory Jobs; North Wales, Rahway (Montgomery County, NJ); Hybrid; USD 173,000 - 273,000; Full time

Job summary

Merck (United States) seeks a Sr. Director and Head of GDMS Process & Quality Management to lead development, implementation, and oversight of the GDMS framework, training compliance, and quality management activities.

Reporting to the Head of Global Data Management and Standards, this role sets the vision for the organization and ensures timely, high‑quality delivery of services. The role partners with clinical programs, trial teams, and quality/compliance groups to ensure audit readiness, CAPA

Qualifications

• 10+ years in clinical data management within the pharmaceutical or biotech industry.
• 5+ years directing or managing process and quality management operations.
• 5+ years leading or supervising managers in a global matrixed organization.
• Experience managing CDM processes across full lifecycle (planning, start-up, conduct, close-out).
• Experience guiding programs through audits, inspections, and CAPA management.

Responsibilities

• Establish and maintain the GDMS operating model, governance cadence, priorities, and escalation pathways.
• Serve as Process Owner for all GDMS processes and lead the SPO network.
• Partner with GDMS Ops to align training strategy with process requirements.
• Ensure GDMS documentation and training meet regulatory requirements.
• Assess process changes for documentation, training, and inspection readiness.
• Engage with clinical programs to resolve escalated quality issues.
• Act as primary GDMS contact for audits and inspections; oversee CAPA responses.
• Lead COE for BPM to translate lessons into sustainable improvements.
• Develop and monitor metrics to identify gaps and drive improvements.
• Engage stakeholders to maintain high quality and compliant delivery.

Skills

Data Management

Quality Management

GCP/ICH

Leadership

Regulatory Compliance

Audits & CAPA

Education

Bachelor’s degree in life sciences/healthcare field

Tools

Clinical Trial Technologies

Documentation Systems

Job description

Merck (United States) seeks a Sr. Director and Head of GDMS Process & Quality Management to lead development, implementation, and oversight of the GDMS framework, training compliance, and quality management activities.

Reporting to the Head of Global Data Management and Standards, this role sets the vision for the organization and ensures timely, high‑quality delivery of services. The role partners with clinical programs, trial teams, and quality/compliance groups to ensure audit readiness, CAPA