Global Data Management & Quality Lead - Process Excellence

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) retirement

Paid holidays

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a senior leader to head GDMS Process & Quality Management. Responsible for governance, training, and quality programs, reporting to Global Data Management and Standards. Drive process excellence and inspection readiness across global trials.

The role emphasizes leading a high-performing team, ensuring regulatory compliance, and partnering with clinical programs to resolve complex quality issues.

Qualifications

• Proven knowledge of clinical development, trial operations, data management, and quality management.
• Strong understanding of regulatory requirements (ICH-GCP, FDA/EMA).
• Experience translating complex concepts for executives and stakeholders.

Responsibilities

• Establish and maintain GDMS operating model, governance cadence, and escalation paths.
• Serve as Process Owner for all GDMS processes and direct SPO network.
• Align training strategy with process requirements and role expectations.
• Ensure process documentation and training meet regulatory standards.
• Assess changes for impact on documentation, training, and inspections.
• Manage audits, inspections, CAPA activities across programs.
• Act as COE for process management and translate learnings into improvements.
• Develop metrics to measure effectiveness and drive continuous improvement.
• Engage stakeholders to maintain high quality and compliant delivery.

Skills

Adaptability

Audit Inspections

Clinical Data Management

GCP

GCDMP

Strategic Thinking

Team Leadership

People Leadership

Lean Continuous Improvement

Ethical Standards

Education

Bachelor's degree in life sciences or healthcare-related field

Job description

Merck & Co., Inc. in Rahway, NJ seeks a senior leader to head GDMS Process & Quality Management. Responsible for governance, training, and quality programs, reporting to Global Data Management and Standards. Drive process excellence and inspection readiness across global trials.

The role emphasizes leading a high-performing team, ensuring regulatory compliance, and partnering with clinical programs to resolve complex quality issues.