Senior Director, Head of Global Data Management and Standards; GDMS) Process & Quality Management

Job Description

Job Summary:

The Sr. Director and Head of GDMS Process and Quality Management is responsible for the development, implementation, oversight, and maintenance of the GDMS process and training compliance framework; business processes; associated functional process training; and quality management activities. Reporting to the Head of Global Data Management and Standards, sets the vision for the organization and is responsible for the timely and quality delivery of GDMS Process & Quality Management services.

• 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 (i.e., ICH, GCP)
• Sponsorship and/or leadership of organizational initiatives

• Strategic Planning –Thinks strategically and gains alignment through collaborative stakeholder engagement and influence across development, clinical operations, and quality organizations.
• Execution Excellence
  - Drives reliable, high‑quality delivery by establishing end‑to‑end processes and KPI‑driven measurement approaches to track progress, improve outcomes, and ensure consistent outputs
• Change…