Executive Director, Quality Data Analytics and Process Management

Responsibilities

• Develop and execute a multi-year strategy for process management, data analytics, document management, and risk management aligned to R&D Quality priorities.
• Serve as a strategic advisor to the Head of R&D Quality on process performance, clinical quality trends, operational risk, and digital opportunities.
• Build a high-performing organization focused on innovation, simplification, and measurable business impact.
• Act as business process owner for core R&D Quality processes such as deviations/nonconformances, CAPA, change control, training(metrics), and risk management.
• Support the R&D business process owners to develop global standards, process controls, KPIs, roles/responsibilities, and governance for assigned processes.
• Ensure simplification, standardization, and modernization of document structures and approval workflows in partnership with Global Quality.
• Ensure processes are compliant with applicable GxP regulations and integrated across functional boundaries.
• Lead periodic process reviews, health checks, and continuous improvement initiatives related to these processes.
• Establish a modern analytics strategy for R&D Quality using dashboards, predictive indicators, trend analysis, and self-service reporting tools.
• Develop executive dashboards for quality performance, compliance health, process efficiency, inspection readiness, and risk visibility.
• Champion use of automation, AI-enabled analytics, and digital tools to improve decision-making.
• Develop and lead a comprehensive clinical quality analytics framework supporting risk-based quality management and centralized monitoring across the clinical trial portfolio.
• Identify cross-study and portfolio-level trends that may indicate systemic GCP risks or process weaknesses in partnership with Clinical & Research Quality.
• Integrate risk signals from audits, inspections, deviations, vendors, metrics, and operational changes to delivery comprehensive insights.
• Partner with Clinical Delivery and Study Quality teams to integrate quality signals into ongoing study oversight and risk review forums.
• Use predictive analytics to identify trials, countries, vendors, or sites at increased risk for quality or inspection issues.
• Support inspection readiness through analytics related to TMF completeness, overdue actions, protocol compliance, training status, and vendor oversight performance.
• Develop executive reporting on clinical quality health across Phase I-IV programs, CRO partnerships, and development regions.
• Benchmark internal metrics against industry trends and regulatory expectations where available.
• Build and develop teams across process excellence, analytics, document management, and risk management disciplines.
• Develop organizational capability in process thinking, data literacy, and risk-based decision making.
• Foster a culture of accountability, innovation, and continuous learning.

Qualifications

• Doctorate degree and 6 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management OR Masters degree and 10 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management OR Bachelors degree and 12 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management AND 6 years of managerial experience directly leading people in a multi-tiered organization and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Strong knowledge of GCP, GxP regulations, ICH E6, risk-based quality management, and quality management systems
• Demonstrated success leading analytics, digital transformation, or complex process improvement programs
• Understanding of the legal and regulatory environment, applicable laws, regulations, guidances and health authority expectations globally for drug development and digital processes and Artificial Intelligence
• Proven track record in management and subsequent response to health authority inspections