Global Data Management & Process Quality Leader (Hybrid)

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

Benefits offered by this job

Medical insurance

Retirement benefits (401(k))

Paid holidays & vacation

Job summary

HireLifeScience is seeking a Sr. Director and Head of GDMS Process & Quality Management to lead the development, implementation, and oversight of the GDMS process and training compliance framework.

You will set the vision for the organization, guide quality management activities, and ensure timely delivery of services across global operations. The role requires extensive experience in clinical data management, process leadership, and regulatory standards (ICH, GCP), with a focus on high-quality,

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, including direct line management of managers or program managers in a matrixed, global organization.
• Experience managing, overseeing, and improving clinical data management processes across the full lifecycle (planning, start-up, conduct, close-out, archival).
• Experience preparing, leading and guiding program and study teams through audits, inspections, and CAPA management activities across therapeutic areas.
• Experience with using and/or managing data management and clinical trial technologies including those used by sponsors and 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
• Strategy development, planning, and alignment with organizational goals and priorities
• Resource forecasting and management to ensure portfolio and other organizational objectives are met
• Leadership of talent development and performance management activities with a focus on building a high-performing team and fostering a culture of growth and development
• Oversight of financial forecasting, budget, and expense management
• Leadership engagement with internal stakeholders and industry leaders to identify opportunities for innovation and continuous improvement
• Ensuring process alignment with regulatory expectations and industry best practice
• Ensuring organizational awareness and compliance with company policies, procedures, mandatory training, and regulatory requirements (ICH, GCP)
• Sponsorship and/or leadership of organizational initiatives

Skills

Strategic Planning

Execution Excellence

Change Catalyst

Networking & Partnerships

Adaptability

Audit Inspections

Clinical Data Management

Quality Management

GCP Knowledge

Team Leadership

People Leadership

Education

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

Job description

HireLifeScience is seeking a Sr. Director and Head of GDMS Process & Quality Management to lead the development, implementation, and oversight of the GDMS process and training compliance framework.

You will set the vision for the organization, guide quality management activities, and ensure timely delivery of services across global operations. The role requires extensive experience in clinical data management, process leadership, and regulatory standards (ICH, GCP), with a focus on high-quality,