Risk Based Quality Management Director

Application process closes: Friday, July 17th.

Locations: US, Canada, LATAM, EMEA, or India.

Overview: Fortrea’s risk–based quality management strategy is entering an exciting new phase. We have critically evaluated our RBQM framework and made deliberate enhancements. We need a leader to advance our capabilities, focusing on technology, AI, and the wider organization. The Director will shape how RBQM is delivered across our clinical operations and build the next generation of RBQM talent.

What You Will Do

• Lead and develop the RBQM organization: provide leadership and line management for RBQM leads; build a high‑performing, engaged, future‑focused function; coach, develop, and mentor professionals; create a culture of accountability, collaboration, innovation, and continuous improvement; and ensure measures of operational RBQM success are developed and implemented.
• Build and scale the RBQM secondment program: develop the program; partner with functional leaders and HR to identify and develop future RBQM talent; create meaningful development opportunities; and help establish a sustainable, scalable model supporting long‑term growth and expertise.
• Drive RBQM capability and training across Fortrea: develop and strengthen enterprise‑wide learning initiatives; partner with functional teams to identify capability gaps and training needs; coordinate training programs, materials, competency development, and effectiveness measurements; support change‑management activities; shape and execute RBQM strategy; guide study teams in implementing effective risk‑management approaches and Quality by Design principles; and use data, metrics, and insights to drive quality and operational improvements.
• Support business growth: provide RBQM expertise during RFPs, RFIs, and proposal development; participate in client meetings and bid defenses; articulate Fortrea’s RBQM strategy and value proposition; and ensure RBQM aligns with evolving client and business needs.
• Drive cross‑functional collaboration: build strong partnerships across Clinical Operations, Project Management, Medical, Data Management, Quality, and other functions; influence without authority; facilitate collaboration; and 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 by 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 deployed.

Qualifications (minimum required)

• Bachelor’s degree (or equivalent experience).

Skills / Competencies

• Expertise in RBQM strategies, processes, tools, and implementation.
• Deep understanding of RBQM, risk‑based monitoring, central monitoring, Quality by Design, 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.
• Ability to drive change and gain alignment across diverse groups at global level.
• Strong leadership presence and ability to lead without direct authority.
• 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

• 10–12 years of clinical research experience.
• 7+ years in key management roles in risk‑based quality management, risk‑based monitoring, or central monitoring.
• Client‑facing roles minimum 3 years; experience in proposal and bid defense.
• 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.
• Proven effectiveness in proactive change management and leading cross‑functional teams.
• Strong collaboration, negotiation, and conflict‑resolution skills.
• Strategic, analytical, and problem‑solving skills with attention to detail and data analytics aptitude.
• Ability to absorb study design/therapeutic area knowledge, identify risks/data trends, and manage issues.
• Financial awareness and ability to utilize financial tracking systems.
• Previous line management experience preferred.
• Experience in business growth, proposals, or strategic stakeholder engagement highly valued.
• Experience developing teams, people, processes, programs, or organizational capability highly desirable.
• Strong financial acumen.

EEO / Accommodations

Learn more about our EEO.