- 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.
Learn more about our EEO & Accommodations request here.
Skills Required
- Bachelor's degree in Life Sciences or equivalent experience
- 5 years in regulatory environment, experience in GXP roles
- Strong understanding of QMS and CAPA processes
- Ability to manage client responsibilities
- Strong communication skills
- Knowledge of GCPs/GxPs
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
