Risk Based Quality Management Director

Risk Based Quality Management (RBQM) Director

Locations: US Canada LATAM EMEA or India

Application process closes: Friday July 17th

Important: To be considered for this role all applicants must upload an up-to-date resume. A cover letter alone will not meet the application requirements.

Lead the Next Chapter of Risk Based Quality Management at Fortrea

Fortreas Risk Based Quality Management strategy is entering an exciting new phase.

Over the last year we have taken the opportunity to critically evaluate our RBQM framework and make some deliberate enhancements. We have strong foundations and have begun transforming when and how risk is identified managed and mitigated across the organization. Now we are looking for the leader who will help take that capability to the next level focusing not just on process but on technology and AI application as well as leading our RBQM Leads and upskilling the wider organization

This newly created Director role represents a unique opportunity to influence how Fortrea delivers RBQM across our clinical operations organization while helping build the next generation of RBQM talent and expertise.

Reporting to the Vice President Quality Enablement & RBQM you will:

• Lead a growing team of RBQM Leads

• Advise on regional and country level RBQM strategies

• Oversee our RBQM secondment program and

• Drive the development of enterprise-wide RBQM training and capability-building initiatives.

You will work closely with senior leaders across Clinical Operations Project Management Data Management Medical and Business Development helping ensure RBQM becomes an integral part of how Fortrea delivers studies while supporting business growth and operational excellence.

This is more than a leadership role. It is an opportunity to shape strategy influence change develop people and leave a lasting impact on how Fortrea delivers risk-based quality management across the organization.

WHAT YOU WILL DO

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

Build and Scale the RBQM Secondment Program

• Lead the development and growth of Fortreas 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.

• Coordinate 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 Fortreas 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 Fortreas 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

Success in this role will be measured through:

• 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)

• Bachelors degree required.

• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

SKILLS/COMPETENCIES

We are looking for a leader who combines strategic thinking people leadership and broad organizational influence.

The ideal candidate will demonstrate:

• 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.

• 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

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