This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
In this vital role as the Executive Director, R&D Quality Data Analytics & Process Management, you will lead the strategy, governance, and continuous improvement of core quality processes, document management, enterprise data analytics, and risk management for the Research & Development (R&D) Quality organization. This leader will serve as the business process owner for key Quality Management System (QMS) processes supporting global R&D operations and ensure processes are efficient, compliant, scalable, and aligned with evolving regulatory expectations.
Job Responsibility
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
Requirements
Doctorate degree and 6 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management
Master's degree and 10 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management
Bachelor's degree and 12 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management
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
Nice to have
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, guidance's 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
What we offer
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns