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
- 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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