Senior Director, Global Data Process & Quality

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

Benefits offered by this job

Hybrid work arrangement

Medical, dental, vision benefits

401(k) retirement plan

Job summary

HireLifeScience is seeking a Sr. Director and Head of GDMS Process & Quality Management to lead the development, implementation, and oversight of the organization's GDMS governance, training, and quality management framework.

The role reports to the Head of Global Data Management and Standards and sets the vision for the department, ensuring timely, high-quality delivery of GDMS services and continuous improvement across processes and training.

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 personnel management, including direct line management in a global matrixed organization.
• Experience managing clinical data management processes across the full lifecycle.
• Experience guiding audits, inspections, and CAPA management across therapeutic areas.
• Experience with data management technologies used by sponsors and vendors.

Responsibilities

• Establishs and maintains GDMS Process & Quality Management operating model and governance cadence.
• Serves as Process Owner for all GDMS processes and guides SPO network.
• Aligns training strategy with process requirements and role expectations.
• Ensures documentation and training are complete, high quality, and compliant.
• Oversees CAPA management and inspection readiness.
• Engages with stakeholders to maintain high quality and compliant delivery.
• Contributes to organizational strategy and transformation.

Skills

Strategic Thinking

Team Leadership

Execution Excellence

Change Catalyst

Networking & Partnerships

Adaptability

Audit Inspections

Quality Assurance

Education

Bachelor's degree in life sciences

Tools

Clinical trial technologies

Job description

HireLifeScience is seeking a Sr. Director and Head of GDMS Process & Quality Management to lead the development, implementation, and oversight of the organization's GDMS governance, training, and quality management framework.

The role reports to the Head of Global Data Management and Standards and sets the vision for the department, ensuring timely, high-quality delivery of GDMS services and continuous improvement across processes and training.