Global Head Clinical Services Regulatory Compliance & QA

Role Summary

Global Head Clinical Services Regulatory Compliance & QA. Remote work locations include East Coast, US; UK; Western EU. The role leads quality and regulatory compliance across Fortrea Clinical Services, driving the Quality System, continuous improvement, and operational excellence in global clinical research.

Responsibilities

• Define and execute the Quality System that regulates Fortrea Clinical Services
• Develop and implement a global QA strategy aligned with corporate goals and regulatory expectations
• Ensure adherence to global regulations through the creation and completion of a strong quality risk framework of annual audits. These annual audit plans will confirm compliance of the Fortrea processes, systems, and projects within Fortrea Clinical Services
• Ensure robust CAPA, deviation, audit, and inspection readiness programs are in place
• Represent Regulatory Compliance & Quality Assurance on all potential mergers/acquisitions, along with the subsequent integrations of the target entity

Collaboration

• Serve as a key member of the extended leadership team, contributing to overall business strategy and risk management
• Partner with the business leaders to implement and oversee the quality system, ensuring a collaborative approach to driving a strong culture of quality. Work closely with leadership, clinical operations, legal, corporate compliance, and training to ensure alignment on quality objectives
• Develop proactive measures to mitigate quality-related risks and maintain compliance with global regulatory bodies with the Fortrea Clinical Services business leaders

Development and Continuous Improvement

• Identify and implement continuous improvement initiatives to enhance operational and QA efficiency and reduce risks
• Build, lead, and mentor a high-performing global QA team
• Oversee the QA team to serve as the primary contact in regulatory inspections and audits of Fortrea

Metrics, Measurements and Reporting

• Establish Key Quality Metrics/Indicators, analyze trends, and report findings to executive leadership for informed decision-making
• Represent Regulatory Compliance & Quality Assurance QMS data, actions, and risks in senior leadership meetings such as the Executive Committee, and in stage-up to the Board of Directors
• Direct the enhancements and functionality improvements of the Fortrea QMS Quality Vault for Clinical QA

Qualifications

• Advanced degree in Life Sciences preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.”
• Proven leadership experience in a global QA role
• In-depth knowledge of ICH-GCP, FDA, EMA, and other international regulatory standards
• Experience directing global audits and regulatory inspections
• Experience leading global teams

Experience

• Minimum 15 years of experience in clinical QA within a CRO, pharmaceutical, or biotech environment
• 20 years of experience in the clinical research industry

Preferred Qualifications

• Experience with digital QA systems and eQMS platforms
• Familiarity with decentralized trials and digital health technologies