Global Data Management & Process Quality Director

Merck; North Wales (Montgomery County); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation and sick days

Job summary

Merck is seeking a Sr. Director and Head of GDMS Process & Quality Management to lead the development, implementation and oversight of the GDMS framework. You will set vision, ensure timely, quality delivery, and oversee process training compliance across the organization.

You will drive governance, partner with operations, manage inspections, and lead improvement initiatives while reporting to the Head of Global Data Management and Standards. Hybrid US-based role with global impact.

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 of experience and demonstrated success in personnel management.
• Experience managing clinical data management processes across the full lifecycle.
• Experience preparing and guiding audits, inspections, and CAPA activities.
• Experience with data management and clinical trial technologies.

Responsibilities

• Establishes and maintains the GDMS operating model and governance cadence.
• Serves as Process Owner for all GDMS processes and oversees SPO network.
• Partners with operations to align training with process requirements.
• Ensures documentation and training are compliant with regulatory requirements.
• Engages with clinical programs to resolve escalated GDMS issues.
• Acts as primary GDMS contact for audits and CAPA management.
• Leads Center of Excellence for process, training, and documentation improvements.
• Develops performance metrics and drives continuous improvement.
• Engages stakeholders to maintain high quality and compliant delivery.
• Contributes to organizational strategy as a GDMS leader.

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, medicine, pharmacy, nursing, health informatics, or other healthcare-related field

Job description

Merck is seeking a Sr. Director and Head of GDMS Process & Quality Management to lead the development, implementation and oversight of the GDMS framework. You will set vision, ensure timely, quality delivery, and oversee process training compliance across the organization.

You will drive governance, partner with operations, manage inspections, and lead improvement initiatives while reporting to the Head of Global Data Management and Standards. Hybrid US-based role with global impact.