GCP QA Strategy Director (Inspection Readiness)

Beeline Medicines; Boston (MA); Híbrido; USD 266.000 - 344.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work arrangement

Competitive benefits

Descripción de la vacante

Beeline Medicines is seeking a Senior Director, GCP Quality Assurance to provide strategic leadership for GCP QA across our clinical development programs. This role ensures trials are compliant, auditable, and inspection-ready, partnering with Clinical Operations, Regulatory Affairs, and external service providers.

The candidate will own risk-based QA programs, vendor oversight, CAPA management, and the maturation of fit-for-purpose GCP processes throughout the clinical lifecycle.

Formación

• Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
• 12+ years in GCP QA or clinical quality in biotech/pharma/CRO.
• Director-level leadership experience; ≥3 years people management.
• Deep knowledge of ICH E6, FDA regulations, EU CT Regulation; inspection readiness.
• Experience overseeing CROs, vendors, and external QA in outsourced/hybrid models.

Responsabilidades

• Define, implement, and mature the GCP QA strategy across clinical programs.
• Serve as senior GCP QA partner to cross-functional teams and suppliers.
• Champion quality, compliance, patient safety, data integrity and continuous improvement.
• Lead and develop GCP QA capabilities and external QA resources.
• Oversee vendor qualification, audit strategy, CAPA and inspection readiness.
• Review and approve GCP-related quality agreements, plans and training materials.
• Provide senior QA oversight for CROs, sites, and service providers.

Conocimientos

Executive presence

Cross-functional influence

Leadership

Risk-based quality management

Regulatory understanding

Educación

Bachelor’s degree in scientific field

Advanced degree preferred

Herramientas

Veeva

eTMF system

Descripción del empleo

Beeline Medicines is seeking a Senior Director, GCP Quality Assurance to provide strategic leadership for GCP QA across our clinical development programs. This role ensures trials are compliant, auditable, and inspection-ready, partnering with Clinical Operations, Regulatory Affairs, and external service providers.

The candidate will own risk-based QA programs, vendor oversight, CAPA management, and the maturation of fit-for-purpose GCP processes throughout the clinical lifecycle.