Global Head Clinical Services Regulatory Compliance & QA

Remote Work locations:

East Coast US

UK

Western EU

Job Overview:

This leader will report into the Chief Quality Regulatory and Sustainability Officer along with the leaders of the Clinical Pharmacology Services QA team the Head of the Global Quality Office and the ESG Leader. Collectively this leadership team is responsible for creating and driving the Quality System at Fortrea. This leader will bring deep expertise in the conduct of global clinical research a strategic mindset and collaborative leadership style to drive continuous improvement and operational excellence.

The Global Head of the Clinical Services Regulatory Compliance & Quality Assurance (RCQA) unit is responsible to create the strategy budgetary requirements and alignment of resources to deliver compliance and quality solutions across Fortrea Clinical Services. This leader will serve as the business partner to the President of Fortrea Clinical Services to deliver a strong overarching culture of quality and regulatory compliance to all applicable laws standards certifications and contractual agreements.

Summary of Responsibilities:

Fortrea Quality System

• 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 (Minimum Required):

• 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 Required):

• 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 Include:

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

Learn more about our EEO & Accommodations request here.