Global Head Clinical Services Regulatory Compliance & QA

Role Summary

Location: East Coast. The Global Head of Clinical Services Regulatory Compliance & QA will lead Fortrea Clinical Services' quality and regulatory compliance efforts, reporting to the Chief Quality, Regulatory, and Sustainability Officer. This role partners with senior leaders to create and drive the Quality System and to deliver compliance with applicable laws, standards, certifications, and contractual requirements. The role requires deep global clinical research expertise, strategic leadership, and a focus on continuous improvement and operational excellence.

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
• 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
• 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
• 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

• Preferred: Advanced degree in Life Sciences or equivalent experience; Fortrea may consider relevant and equivalent experience in lieu of educational requirements
• Required: Proven leadership experience in a global QA role
• Required: In-depth knowledge of ICH-GCP, FDA, EMA, and other international regulatory standards
• Required: Experience directing global audits and regulatory inspections
• Required: Experience leading global teams
• Required: Minimum 15 years of experience in clinical QA within a CRO, pharmaceutical, or biotech environment
• Required: 20 years of experience in the clinical research industry
• Preferred: Experience with digital QA systems and eQMS platforms
• Preferred: Familiarity with decentralized trials and digital health technologies