About this role
Summary of Responsibilities
• Serves as the primary Quality Lead and trusted advisor for assigned client accounts and strategic programs.
• Acts as the primary quality point of contact for sponsor quality governance, compliance discussions, risk reviews, and quality escalations.
• Leads client quality governance meetings and presents quality metrics, risk trends, CAPA status, inspection readiness indicators, and continuous improvement activities.
• Provides proactive quality oversight and strategic advice to operational teams and clients throughout the clinical trial lifecycle.
• Partners with cross-functional leaders to identify, assess, and mitigate quality and compliance risks.
• Supports and leads client audits, regulatory inspections, due diligence activities, and inspection readiness initiatives.
• Provides oversight of significant quality events, investigations, root cause analyses, and CAPA development to ensure robust and sustainable actions.
• Performs trend analysis of quality data, audit findings, inspections, CAPAs, deviations, and compliance metrics to identify systemic risks.
• Ensures quality-related client notifications and escalations are managed in accordance with applicable procedures and contractual obligations.
• Supports business development activities including client presentations, proposals, and quality due diligence discussions.
• Acts as a subject matter expert in GCP, quality management systems, inspection readiness, and risk-based quality management.
• Provides mentorship, coaching, and guidance to quality and operational teams while promoting a culture of quality and continuous improvement. Qualifications
• Bachelor’s degree in Life Sciences or equivalent experience.
• Advanced quality, regulatory, or clinical research qualifications preferred. Experience
• 8–10 years of experience in GCP-regulated clinical research, quality assurance, regulatory compliance, or clinical operations.
• Demonstrated experience in sponsor-facing quality leadership roles.
• Experience managing regulatory inspections, client audits, and quality governance programs.
• Strong understanding of QMS, CAPA management, quality risk management, and inspection readiness.
• Experience working within a CRO and/or sponsor environment.
• Excellent stakeholder management, communication, and executive presentation skills. Core Competencies
• Client relationship management
• Strategic quality leadership
• Risk-based decision making
• Executive communication
• Inspection readiness leadership
• Cross-functional influence
• ICH E6(R3), FDA, EMA, MHRA, and GxP expertise Qualifications (Minimum Required):
• A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience). • Experience may be substituted for education. • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required):
• 5 years in regulatory environment (experience in GXP roles). • Strong understanding of QMS and CAPA processes. • Ability to manage client responsibilities. • Report and communicates key quality information to Sr. Managers and QA. • Able to work effectively within a team environment. • Able to communicate effectively during client meetings • Knowledge of GCPs/GxPs.
Physical Demands/Work Environment:
• Flexibility in working outside office may be needed to work with global team and clients • Occasional travel required.
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