Senior Director, GCP QA & Inspection Readiness

BioSpace; Cambridge (MA); Híbrido; USD 266.000 - 344.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health coverage

Paid time off

Hybrid work arrangement

Descripción de la vacante

Beeline Medicines is seeking a Senior Director of GCP Quality Assurance to provide strategic leadership and operational oversight of GCP QA activities across clinical development programs. You will ensure trials are conducted and reported in compliance with global GCP standards while maintaining inspection readiness and a strong quality culture.

The role reports to senior leadership and partners with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Data Management, and external

Formación

• Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
• 12+ years of progressive GCP Quality Assurance or Clinical Quality experience in biotech/pharma/CRO.
• Experience leading or managing GCP audits and regulatory inspections, including inspection preparation, conduct, CAPA oversight, and follow‑up.

Responsabilidades

• Define, implement, and mature the GCP QA strategy aligned with clinical development objectives and regulatory expectations.
• Provide senior QA leadership to CROs, investigator sites, vendors, and external partners.
• Lead inspection readiness, mock inspections, CAPA planning, and regulatory observation closure.

Conocimientos

GCP Quality Assurance

Quality risk management

Audit management

Vendor oversight

Regulatory inspections

Cross‑functional collaboration

Leadership

Educación

Bachelor’s degree in a scientific or related discipline

Advanced degree preferred

Herramientas

eTMF

GxP systems

Veeva or similar platforms

21 CFR Part 11

Descripción del empleo

Beeline Medicines is seeking a Senior Director of GCP Quality Assurance to provide strategic leadership and operational oversight of GCP QA activities across clinical development programs. You will ensure trials are conducted and reported in compliance with global GCP standards while maintaining inspection readiness and a strong quality culture.

The role reports to senior leadership and partners with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Data Management, and external