Global Data Management & Quality COE Director

MSD; Rahway (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

MSD in Rahway, NJ seeks a Sr. Director and Head of GDMS Process and Quality Management to lead development, implementation, and maintenance of the GDMS process and training framework for timely, high-quality delivery of GDMS services.

Reporting to the Head of Global Data Management and Standards, this role sets the vision for the organization, oversees audits and CAPA, and drives continuous improvement while partnering with stakeholders to align processes, training, and regulatory compliance

Qualifications

• Bachelor’s degree in life sciences or healthcare field.
• 10+ years in clinical data management in pharma/biotech.
• 5+ years leading process and quality management operations.
• 5+ years personnel management in a global matrix org.
• Experience managing CDM processes across lifecycle.
• Experience with audits, inspections, CAPA management.
• Experience with CDM tech used by sponsors/vendors.

Responsibilities

• Establishes and maintains the GDMS Process & Quality Management operating model, governance cadence, priorities, decision rights, and escalation pathways to drive consistent execution and accountability.
• Serves as the Process Owner (PO) for all GDMS processes, oversights GDMS process development and maintenance, and directs the network of GDMS Sub- Process Owners (SPO) to ensure that business processes are effectively coordinated and aligned.
• Partners with GDMS Business Operations and other stakeholders to align functional training strategy with process requirements and role expectations.
• Ensures that GDMS process documentation and associated functional training is complete, aligned, of high quality, and compliant with regulatory requirements.
• Ensures process changes are assessed for impact to documentation, role expectations, functional training requirements, and inspection readiness.
• Engages with clinical programs and clinical trial teams to resolve escalated GDMS quality and compliance issues that are unable to be resolved at lower levels within the organization.
• Serves as primary GDMS point of contact for audits and inspections, oversees GDMS responses, and ensures timely and effective CAPA management.
• Serves as the 'Center of Excellence' (COE) for business process management ensuring that inspection, audit, CAPA, and quality issue learnings are translated into sustainable process, training, documentation, and capability improvements.
• Develops and monitors performance metrics, trends, and risk indicators to assess effectiveness, identify capability gaps, and drive continuous improvement.
• Proactively engages with stakeholders, functional area leaders, quality and compliance organizations, and regulatory inspectors, ensuring that GDMS maintains high quality and complaint performance.
• As a member of the GDMS Leadership team, actively contributes to organizational strategy, planning, and transformation.

Skills

Strategic Planning

Execution Excellence

Change Catalyst

Networking & Partnerships

Education

Bachelor's degree in life sciences, medicine, pharmacy, nursing, health informatics, or other healthcare-related field

Job description

MSD in Rahway, NJ seeks a Sr. Director and Head of GDMS Process and Quality Management to lead development, implementation, and maintenance of the GDMS process and training framework for timely, high-quality delivery of GDMS services.

Reporting to the Head of Global Data Management and Standards, this role sets the vision for the organization, oversees audits and CAPA, and drives continuous improvement while partnering with stakeholders to align processes, training, and regulatory compliance