Remote Senior Director, Project Quality & Compliance

Flourish Research; United States; A distancia; USD 150.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, dental, and vision insurance

Descripción de la vacante

Flourish Research is seeking a Senior Director, Project Quality to lead all project quality functions across sites. The role oversees the Flourish QMS, drives quality improvements, and manages the Project Quality team to ensure regulatory compliance and patient safety.

The position is remote with travel up to 30% and requires a Master’s degree plus 8+ years in clinical quality/compliance. Strong leadership and communication skills are essential as you mentor staff and collaborate across

Formación

• Master’s degree or equivalent required with 8+ years in quality/compliance in clinical research.
• Expert knowledge of GCP, FDA guidance, and site conduct in clinical trials.
• Proven ability to build and manage a QMS and drive quality initiatives.

Responsabilidades

• Build, implement, and manage a companywide QMS across Flourish Research sites.
• Lead the Project Quality team and oversee quality management processes.
• Prepare sites for sponsor audits and manage regulatory communications.
• Collaborate with Process Quality on process improvements and SOP harmonization.
• Report quality metrics, CAPAs, QIs to senior leadership.

Conocimientos

Quality management

GCP knowledge

Leadership

Regulatory compliance

Cross-functional leadership

Risk assessment

Site audits & inspections

Quality metrics & CAPA

Educación

Master’s degree or equivalent

Herramientas

Office365

Descripción del empleo

Flourish Research is seeking a Senior Director, Project Quality to lead all project quality functions across sites. The role oversees the Flourish QMS, drives quality improvements, and manages the Project Quality team to ensure regulatory compliance and patient safety.

The position is remote with travel up to 30% and requires a Master’s degree plus 8+ years in clinical quality/compliance. Strong leadership and communication skills are essential as you mentor staff and collaborate across