Risk Based Quality Management Director

Lead the Next Chapter of Risk Based Quality Management

Lead and Develop the RBQM Organization

• Provide leadership and line management for the RBQM Leads.
• Build a high-performing, engaged, and future-focused RBQM function.
• Coach, develop, and mentor RBQM professionals while supporting career growth and succession planning.
• Create a culture of accountability, collaboration, innovation, and continuous improvement.
• Ensure measures of operational RBQM success are developed and implemented.

Ensure measures of operational RBQM success are developed and implemented

Build and Scale the RBQM Secondment Program

• Lead the development and growth of Fortrea's RBQM secondment program.
• Partner with functional leaders and HR to identify and develop future RBQM talent.
• Create meaningful development opportunities that strengthen RBQM capability across the wider organization.
• Help establish a sustainable and scalable model that supports long-term organizational growth and expertise.

Drive RBQM Capability and Training Across Fortrea

• Develop and strengthen enterprise-wide RBQM learning and development initiatives.
• Partner with functional teams to identify capability gaps and training needs.
• Cook up training programs, materials, competency development, and effectiveness measurements.
• Support change management activities that improve RBQM adoption across the organization.

Shape and Execute RBQM Strategy

• Partner with senior leadership to drive Fortrea's RBQM vision and strategic objectives.
• Lead RBQM initiatives across studies, programs, and portfolios.
• Guide study teams in implementing effective risk management approaches and Quality by Design principles.
• Support continuous enhancement of RBQM processes, methodologies, tools, and frameworks.
• Use data, metrics, and insights to drive quality and operational improvements.

Support Business Growth

• Provide RBQM expertise during RFPs, RFIs, and proposal development activities.
• Participate in client meetings and bid defenses.
• Help articulate Fortrea's RBQM strategy and value proposition to customers.
• Ensure RBQM remains aligned with the evolving needs of our clients and business.

Drive Cross-Functional Collaboration

• Build strong partnerships across Clinical Operations, Project Management, Medical, Data Management, Quality, and other functional areas.
• Influence without authority and successfully navigate complex stakeholder environments.
• Facilitate collaboration that strengthens RBQM adoption and organizational effectiveness.
• Act as a trusted advisor to leaders across the business.

Key Performance Indicators

• Effective leadership and development of the RBQM Leads team.
• Successful implementation and growth of the RBQM secondment program.
• Increased RBQM capability and proficiency across the organization.
• Adoption of RBQM practices across assigned portfolios and functions.
• Stakeholder satisfaction and cross-functional partnership effectiveness.
• Process, quality, and risk-management improvements driven through RBQM initiatives.
• Contribution to business growth and client engagement activities.
• Enterprise awareness of RBQM strategy and deployment.
• Reduction in quality events and increase in NPS on studies where the enhanced RBQM strategy has been fully deployed.

Qualifications (Minimum Required)

• Bachelor’s degree required.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Skills/Competencies

• Combines strategic thinking, people leadership, and broad organizational influence.
• Expertise in RBQM strategies, processes, tools, and implementation.
• Deep understanding of RBQM, risk-based monitoring, central monitoring, Quality by Design (QbD), risk/issue management, root cause analysis, and cross-functional RBQM interfaces.
• Knowledge of RBQM IT systems and data flows.
• Proven ability to build strong networks and influence across functions and leadership levels.
• Experience leading complex initiatives in matrix organizations.
• Strong stakeholder management and relationship-building skills.
• Excellent communication, presentation, and facilitation abilities.
• Strategic thinking and problem-solving capabilities.
• The ability to drive change and gain alignment across diverse groups at global level.
• Strong leadership presence and the ability to lead without direct authority.
• A collaborative mindset with a passion for developing people and capability.
• Understanding of RBQM, Quality by Design, clinical trial execution, or related quality and operational improvement disciplines.
• Experience minimum required 10-12 years clinical research experience.
• 7+ years in key management roles in risk-based quality management, risk-based monitoring, or central monitoring (preferred).
• Client-facing roles experience is mandatory. 3+ years in client facing roles is preferred.
• Experience leading cross-functional initiatives and influencing stakeholders across organizational boundaries.
• Experience working with senior leaders and navigating complex business environments.
• Demonstrated success delivering operational, transformation, quality, or capability-building initiatives.
• Experience working across multiple therapeutic areas and global teams.
• Experience in risk management, audits, inspections, root cause analysis, mitigation, and CAPA.
• Proven ability to analyze data, identify patterns, and recommend improvements.
• Demonstrated effectiveness in proactive change management and leading cross functional teams.
• Strong collaboration, client-facing, negotiation, and conflict resolution skills.
• Strategic thinking, analytical, and problem-solving skills with attention to detail and data analytics aptitude.
• The ability to absorb study design/therapeutic area knowledge, identify risks/data trends, and manage issues.
• Financial awareness and ability to actively utilize financial tracking systems.
• Highly valued previous line management experience is preferred.
• Candidates without direct line management responsibility should be able to demonstrate successful leadership and influence within matrix organizations.
• Experience in business growth, proposals, or strategic stakeholder engagement is highly interesting.
• Experience developing teams, people, processes, programs, or organizational capability is highly desirable.
• Strong financial acumen.