Instagram
youtube
Facebook

Global Head Clinical Services Regulatory Compliance & Qa

15+ years
Not Disclosed
10 Oct. 7, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Global Head, Clinical Services Regulatory Compliance & QA

Category: Regulatory/Compliance
Job ID: 253978
Locations (Remote):

  • East Coast, US

  • UK

  • Western EU


🌟 Role Overview

Fortrea is seeking a strategic, collaborative leader to oversee global Clinical Services Regulatory Compliance & Quality Assurance (RCQA). Reporting to the Chief Quality, Regulatory, and Sustainability Officer, this role drives operational excellence, quality culture, and regulatory compliance across Fortrea Clinical Services.

The leader will partner with the President of Clinical Services and other senior leaders to implement a robust, global QA framework ensuring compliance with laws, standards, certifications, and contractual agreements.


🏆 Key Responsibilities

Fortrea Quality System

  • Define, execute, and maintain the Quality System for Fortrea Clinical Services

  • Develop and implement a global QA strategy aligned with corporate goals and regulatory expectations

  • Ensure adherence to global regulations through audits, CAPA, deviations, and inspection readiness

  • Represent RCQA in mergers, acquisitions, and integrations

Collaboration

  • Act as a key member of the extended leadership team contributing to business strategy and risk management

  • Partner with business leaders, clinical operations, legal, corporate compliance, and training to align on quality objectives

  • Implement proactive measures to mitigate quality-related risks globally

Development and Continuous Improvement

  • Identify and implement continuous improvement initiatives to enhance operational and QA efficiency

  • Build, mentor, and lead a high-performing global QA team

  • Oversee the QA team as primary contact for regulatory inspections and audits

Metrics, Measurements, and Reporting

  • Establish Key Quality Metrics/Indicators, analyze trends, and report findings to executive leadership

  • Represent QMS data, actions, and risks in senior leadership meetings and board discussions

  • Direct enhancements and functionality improvements of the Fortrea QMS Quality Vault for Clinical QA


🎓 Qualifications

Minimum Required

  • Advanced degree in Life Sciences preferred (relevant experience may substitute for education)

  • Proven leadership experience in a global QA role

  • Deep 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 clinical QA experience within a CRO, pharmaceutical, or biotech environment

  • 20 years of overall experience in the clinical research industry

Preferred

  • Experience with digital QA systems and eQMS platforms

  • Familiarity with decentralized trials and digital health technologies


Work Environment

  • Remote work with occasional collaboration and travel as needed

  • Exposure to regulatory and compliance environments across multiple geographies


📋 Additional Information

  • Leadership role responsible for strategy, compliance, and quality culture at a global level

  • Directly contributes to operational excellence and Fortrea’s position as a trusted partner in clinical research